Weight Loss Intervention for Mothers With Young Children
Phase: NA
Conditions: Obesity, Weight Loss
Sponsor: Ohio State University

 
 
1 
 
 
 
Official Title: Lifestyle Behavior Weight Loss 
Intervention 
NCT Number: NCT04649047 
Document Name: Study Protocol and Statistical Analysis Plan 
Document Date: November 18, 2022 
 
 
 

 
 
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Research Protocol 
 
Weight Loss Intervention for Mothers with Young Children 
 
I. 
Objectives   
 
1. Assess intervention fidelity (dose, delivery, receipt) and acceptability by the study participants  
2. Investigate potential intervention impact on the primary (body weight) and secondary outcomes (pants size)  
3. Explore potential intervention impact on lifestyle behaviors (diet and physical activity) 
4. Explore potential intervention impact on motivation (autonomous motivation, self-efficacy, social support), 
emotion (emotion control, stress), and cognition (impulsivity). 
5. Assess cost of different recruitment approaches 
 
II. 
Background and Rationale 
Low-Income Overweight or Obese Mothers of Young Children: Our Priority Population. In the 
U.S., nearly 50% of low-income women aged 20-40 years are at high risk for type 2 diabetes, because they 
live in poverty and are overweight or obese (body mass index [BMI] ≥ 25.0 kg/m2).1-4 One-year postpartum, 
low-income women have over twice the risk (68-75%) for significant weight retention (≥ 10 lbs) compared to 
higher-income women (32%).5 Significant postpartum weight retention is a strong predictor for lifelong obesity6 
and adverse maternal and birth outcomes, such as gestational diabetes and macrosomia7-13 during subsequent 
pregnancies. Weight gain of ≥ 11 lbs during young adulthood increases risk for obesity-related conditions 
including type 2 diabetes,14 which can be delayed and reduced by weight loss.15  
 
Current Lifestyle Weight Loss Intervention Studies. Two recent meta-analyses16,17 and an individual 
effectiveness intervention study18 have shown that healthy lifestyle behaviors (healthy eating, PA) promote 
postpartum weight loss, including for low-income, overweight or obese women.18 Despite the promise of the 
existing research, most prior studies have had relatively small sample sizes, mainly due to limitations for 
enrolling women within one year postpartum16,17 -- high infant care demands prevent women from participating 
in intervention studies.16 This is a missed opportunity to have broader impact on the obesity epidemic19 and 
pregnancy-related maternal outcomes, because 40-50% of obese women gain ≥ 2 BMI units between 
pregnancies.20 Also, prior studies paid little or no attention to mechanisms of motivation (autonomous 
motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition (executive function), 
all of which play important roles in healthy lifestyle behaviors and resulting positive health outcomes.21-30 
Finally, previous lifestyle interventions have involved costly staff involvement that would be difficult or 
impossible to scale up and maintain in clinical practice.31 The previous research suggests that progress is 
possible but fails to provide clinically-feasible and scalable options. Thus, there is an urgent need to test 
scientifically rigorous, novel intervention programs, like the one that we proposed, for achieving weight loss in 
the priority population that could also potentially address feasibility limitations of prior work.  
 
Scientific Premise. Previous research strength. Lifestyle interventions can promote weight loss. 
Previous research limitations. (1) The proposed priority population has been significantly underrepresented 
in prior lifestyle weight loss intervention studies. (2) Prior lifestyle interventions in overweight or obese mothers 
have suffered from threats to internal validity and have not specifically addressed motivation, emotion, and 
cognition (especially executive function), all of which are critical for promoting and maintaining healthy lifestyle 
behaviors and health outcomes. (3) There has been little evidence that any of the potentially efficacious 
strategies researched previously were even possible under real-world conditions. The proposed small pilot 
study builds on strength and effectively addresses limitations of prior research. The ultimate goal of the 
proposed study is to create a more feasible and scalable intervention that can be easily implemented and 
sustained in real-world settings. We propose to assess intervention fidelity and acceptability; we also 
investigate the potential utility of a web-based intervention in which participants identify their motivation for 
making positive behavior change, weekly goals, and means of attaining those goals, supplemented by periodic 
individual phone calls. Moreover, we will assess cost of different recruitment approaches. Significance. The 

 
 
3 
 
proposed study will add scientific knowledge on intervention implementation in a hard-to-reach population at 
high risk for type 2 diabetes.  
 
Conceptual Framework 
 
 
The proposed lifestyle weight loss intervention study will be the first to jointly apply future time 
perspective and Self-Determination Theory concepts (motivation [autonomous motivation, self-efficacy, social 
support], emotion (emotion control, stress), and cognition (executive function). Conceptual Framework 
(Figure 1). We use Future Time Perspective Theory (anticipation of future goals or personal experience across 
the past, present, and future32) as a guiding conceptual framework. Future time perspective drives motivation 
and behavior in everyday life.33 Future Time Perspective Theory concepts include motivation,34 emotion,33 and 
cognition.35 Implementation of future time perspective has focused on episodic future thinking.35 We also apply 
key concepts from Self-Determination Theory: Autonomous motivation, competence (self-efficacy), and 
relatedness (social support), all of which foster motivation and activity engagement.36 Self-Determination 
Theory -based interventions have effectively promoted and maintained healthy eating,22,37 physical activity,38 
weight loss,23,39-41 goal progress,42 and intervention adherence.39 Our preliminary work with the proposed 
priority population supports the study conceptual framework. A lifestyle intervention including stress 
management can effectively reduce stress43 and fat intake.44 Stress was positively associated with fat intake.45 
Self-efficacy and social support buffer stress46 and dietary intake47,48 Autonomous motivation and self-efficacy 
mediated the association between a lifestyle intervention and fat intake.49 Self-efficacy mediated the 
association between a lifestyle intervention and stress.47 Using an ActiGraph accelerometer (ActiGraph) to 
measure physical activity in the proposed population,50 we found that 33.3% met physical actviity 
recommendations (≥ 150 min/week moderate physical activity), 23.9% had some but were below the 
recommendations, and 42.8% had no physical activity. The proposed Goal-oriented EFT (GoEFT) 
intervention has two unique components that differentiate it from our own and other previous research: weekly 
self-directed and interactive web site (web) and individual counseling via Zoom. The vivid imagination 
(visualization, episodic future thinking) of goal-relevant future events in the individual’s life51 is specifically 
designed to improve motivation (autonomous motivation, self-efficacy, social support), emotion (emotion 
control, stress), and cognition (executive function), all of which promote success in achieving goals for healthy 
lifestyle behaviors. Key lifestyle behaviors include dietary intake (fewer calories, less fat and sugary drinks, and 
more fruit and vegetables) and physical activity (increase light-to-moderate physical activity). The proposed 
light-to-moderate physical activity is a realistic goal for the priority population and is consistent with public 
health recommendations that even modest increases in daily physical activity can yield measurable health 
benefits.52-56 The primary outcome is weight loss (body weight) and the secondary outcome is waist 
circumference -- stronger predictors of obesity-related chronic conditions than BMI.57-62  
 
Goal-oriented (Go)
episodic future
thinking (EFT)
-A weekly
self-directed &
interactive web site
(web, up to 40
min/week)
-Weekly individual
counseling via Zoom
(15 min/call)
Motivation
-Autonomous motivation
-Self-efficacy
-Social support
Emotion
-Emotion control
-Stress
Cognition
-Executive function
Dietary intake
-Fat
-Fruit and vegetables
-Sugary drink
Physical activity
-light-to-moderate
PA
Primary outcome
-Body weight
Secondary outcome
-Waist circumference
Three-Week Intervention
Future Time Perspective
and Self-Determination
Theory Concepts
Lifestyle Behaviors
Health Outcomes
Figure 1. Study Conceptual Framework

 
 
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Connecting Episodic Future Thinking to the Proposed Mechanisms. Goal-oriented episodic 
future thinking29 is a promising approach to improve motivation, emotion, and cognition (the proposed 
mechanisms connecting the intervention to the targeted lifestyle behaviors and health outcomes). 
Neuroimaging63-66 and fMRI67-69 studies have shown that episodic future thinking activates the common core 
network of brain regions associated with executive function during daily activity and brain regions associated 
with emotion regulation, decision-making, and memory. Influences on motivation: autonomous motivation, 
self-efficacy, and social support. Autonomous motivation -- will to engage in a behavior because of personal 
value, interest, or choice -- is important for achieving one’s goals.36 Self-efficacy refers to beliefs that one can 
successfully undertake an action.70 Social support means receipt of various types of support, such as help from 
friends, family members, or others.71 Episodic future thinking increases motivation by facilitating the link 
between goals and actions and by enhancing the subjective likelihood and/or value of a goal.72 Influences on 
emotion: emotion control and stress. Emotion control, one’s ability to manage emotional reactions using 
appropriate strategies, is associated with ability to cope with stress.73 Episodic future thinking improves 
emotion,67,74-76 because it activates brain regions associated with emotion regulation.67-69 Influences on 
cognition (executive function). Executive function enables individuals to coordinate thoughts, actions, and 
emotions77 to achieve healthy lifestyle behaviors30,78 and positive health outcomes.30,77 Executive function 
includes inhibitory control (important for EC and resisting temptation to overeat and over-react77), memory, 
reasoning, problem-solving, and planning.77 Executive function enables individuals to take goal-directed 
action.78 Episodic future thinking, especially goal-oriented episodic future thinking,29 effectively increases 
inhibitory control including in overweight or obese women.28,79-81 Such episodic future thinking consequences 
enable reduced energy intake28,29,80,82 promoting weight loss83 by shifting the time perspective of decision 
making84 and activating brain areas associated with prospection.85 Also, episodic future thinking fosters more 
relevant steps in problem solving,86 detailed steps to attain a goal,72 and prospective memory.87 Finally, 
episodic future thinking increases reasoning, problem-solving, and planning.67,72,86,88,89 Thus, there are many 
reasons to expect goal-oriented episodic future thinking to impact the proposed mechanisms.  
 
Connecting Proposed Mechanisms to Each Other and to Lifestyle Behaviors and Health 
Outcomes. Motivation and emotion are inter-related components of self-regulation that enable individuals to 
adhere to a healthy lifestyle and achieve positive health outcomes.90 Motivation. Increased autonomous 
motivation, self-efficacy, and social support are strongly associated with reducing stress in overweight or obese 
women46,47,91 and with promoting cognitive performance92 (e.g., problem solving93) and a healthy lifestyle.21-
25,47,48,94 Also, autonomous motivation predicts successful goal pursuit32,95 and promotes weight 
management.24,40,96,97 Emotion influences cognition.98 Stress negatively affects diet (increased intake of high-
fat, sugary, energy-dense foods, leading to weight gain27) and physical activity.26 Higher levels of stress are 
associated with lower levels of inhibitory control27 and interfere with cognitive performance,99 but reducing 
stress improves executive function.100 Cognition (executive function). Low levels of inhibitory control have 
been associated with increased energy intake in overweight or obese women,79 but high levels of inhibitory 
control have been associated with reduced consumption of total calories, percent calories from fat,28,29 and 
snacking and food intake80,82 in women. Executive function also predicts moderate-to-vigorous PA,30 
maintenance of PA,101 and weight loss.30 Executive function deficits are more likely in overweight or obese than 
normal-weight women102-105 and can be improved through training and practice.100 Thus, previous research 
supports associations among the key mechanisms and connects those mechanisms to healthy lifestyle 
behaviors and to health outcomes.  
 
The study would also be the first to apply episodic future thinking outside the lab with no in-person 
component (emphasizing clinical feasibility). The use of episodic future thinking is more effective for long-term 
motivation and planning than self-generated thought without episodic future thinking. Episodic future thinking 
enables individuals to generate detailed goal-relevant scene construction,64,88,106,107 whereas self-generated 
thought without episodic future thinking focuses on behaviors with minimum or no scene construction.108 With 
the exception of one “internet plus in-person” four-week intervention,83 all prior episodic future thinking studies 
have been conducted in lab settings where participants followed intensive and specific scripts directing them 
through vivid imagination of future events. Thus, the relevance and scalability of episodic future thinking for 
clinical practice remains speculative. Moreover, prior episodic future thinking studies have only focused on one 

 
 
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form of episodic future thinking: episodic simulation (mental representation of the future).67 The proposed 
intervention includes episodic simulation, prediction (benefits for achieving goals), intention (identifying when 
and where the activity will take place), and planning (generating specific steps rather than general plans for 
achieving the goal done by prior research), all of which come together to support prospective cognition.109 
Furthermore, the study would be the first to ask participants to vividly imagine their personal plans followed by 
enabling them to weekly customize the plans. This approach supports the sense of volition and choice and 
fulfilling the psychological needs of the participants, which in turn promotes quality of intervention engagement 
and outcomes.110 Finally, the study would innovate in use of participant-generated short reminders to promote 
cohort retention and intervention dosage.111  
 
A. 
Research Design 
This pilot quasi experimental design study aims to (1) assess intervention fidelity (dose, delivery, 
receipt) and acceptability by the study participants, (2) investigate potential intervention impact on the primary 
(body weight) and secondary outcomes (waist circumference), (3) explore potential intervention impact on 
lifestyle behaviors (diet and physical activity), (4) explore potential intervention impact on motivation 
(autonomous motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition 
(impulsivity), and (5) assess cost of different recruitment approaches. We will enroll 30 overweight or obese 
women with diverse racial and ethnic backgrounds. All measures will be assessed at baseline (T1) and 
immediately after the three-week intervention (T2). 
 
B. 
Sample 
 
Inclusion Criteria. Self-reported 
■ BMI of 25.0-45.0 kg/m2 (calculated using height and weight) ■ Current enrollment in government assistant 
programs (for example, WIC, food stamp (SNAP), or Madicaid) ■ 6 weeks - 5 years postpartum ■ 18-45 years 
old ■ Fluency in speaking, reading, and writing English ■ Ownership of a smart phone with unlimited text 
messages and internet access ■ Committed to a three-week intervention study 
 
Exclusion Criteria. Self-reported 
■ Current pregnancy or lactation ■ Plan to become pregnant during the trial ■ Type 1 or 2 diabetes ■ 
Untreated thyroid disease ■ Drug or alcohol abuse or dependence within last six months ■ Major psychiatric 
disorder (e.g., schizophrenia, bipolar) ■ History of bulimia or anorexia ■ Current taking of appetite suppressant 
or (antipsychotic) medications known to affect body weight ■ Current participation in a weight control or drug 
study ■ Current or planned participation in a commercial weight loss program ■ Previous weight loss surgery ■ 
Contraindications to physical activity.   
 
Sample size/power. We did not perform a formal sample size calculation but based on our available 
funding and resources. Because of budget constraint, we think a sample size of 30 women is appropriate for 
this pilot, which will provide preliminary data for us to apply future NIH R01. 
 
C. 
Measurement/ Instrumentation 
All participants will be assessed at baseline (T1) and immediately after the three-week intervention 
(T2). Survey data will be collected online using password-protected security-ensured Research Electronic Data 
Capture (REDCap), a secure web application for building and managing online surveys and databases. 
Participants will receive up to $10 for completing T1 data collection and $20 for T2 data collection. We will 
contact participants to verify or clarify survey data, e.g., body weight is entered as 90 (most unlikely because 
we will enroll overweight or obese women) instead of 190. 
 
Feasibility. We will use our tracking records to assess recruitment and retention. To assess intervention 
implementation, we will extract data from our study web site that will track and capture details about all 
activities (e.g., amount of and type of activities completed and percent of participants used type in box). We will 
record the attendance of individual coaching session. Participants will report their motivation and barriers 
preventing them from engaging in the intervention activities and evaluate the usefulness of with each episodic 

 
 
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future thinking intervention component.  We will also use semi-structure interview questions (up to 20 
minutes/an individual interview via zoom) to ask participants to evaluate the intervention. We will use website 
tracking data, individual coaching session, and results of zoom interview to revise the intervention contents for 
a future large scale intervention study (R01).  
 
Primary outcome: body weight.  We will collect self-reported body weight. 
 
Secondary outcome: waist circumference. We will collect self-reported pants size, which is a good indicator of 
waist circumference.  
 
Lifestyle behaviors. 
Dietary fat. The NCI brief dietary fat intake survey (16 items)112 will be used to measure dietary fat 
intake. Participants will be asked about frequency of consuming a list of foods. Fruit and vegetable intake. 
NCI five factor screener (9 items) 113 will be used to measure fruit and vegetable intake. Participants will be 
asked about the frequency of eating fruit and vegetables. Sugar intake. NCI five-factor screener (4 items)114 
will be used to measure sugar intake. Participants will be asked about the frequency of eating foods and 
sweeten beverage. Physical activity. The International Physical Activity Questionnaire Short Form (7 items)115 
will be used to measure physical activity. Participants will be asked amount of time spent on physical activities.  
 
Concepts.  
Motivation. Autonomous motivation will be measured using Treatment Self-Regulation Questionnaire 
(18 items) that asks why the respondent does a behavior.116 Self-efficacy will be measured using a 10-item 
survey for general self-efficacy,117 an 8-item survey for healthy eating self-efficacy,118 and a 10-item survey for 
physical activity self-efficacy119 that ask participants’ confidence in performing the specific activity. Social 
support measures ask mothers to report social support from their family members, friends, or other people to 
manage stress (6 items), eat healthier (6 items), and engage in PA (4 items).119 Emotion. Emotion control will 
be measured using the Emotion Regulation Questionnaire (10 items) that assess emotion regulatory process 
using reappraisal, suppression and regulating negative emotion.120 Stress will be measured using The 
Perceived Stress Scale (10 items)121 that measures the degree to which situations in one’s life are appraised 
as stressful.  Cognition. To measure executive function (impulsivity), we will use Barratt Impulsiveness Scale 
(30 items) to measure impulsivity.122 
 
Process evaluation.  
All participants will report receipt of lifestyle behavior counseling from their clinicians, midwifes and 
dietitians and joining other programs.  
 
Recruitment cost 
 
We will track time and effort spend on each recruitment method.  
 
Sent messages to participants 
We will email and text participants to complete study activates. Please note the sequence listed below 
corresponding to the sequence listed on the file called “All Email and Text Messages.” 
 
Activities 
Email 
Text 
Notes 
A. 
Enrollment Phase 
 
 
 
A1. Attend information session (first 
zoom meeting) 
Yes 
Yes 
Up to 3 times  
A2. Full consent to participation 
Yes 
No 
Up to 3 times 
A3. Attend second zoom meeting 
Yes 
Yes 
Up to 3 times 
B. 
Intervention Phase 
 
 
 
B1: Complete Part I intervention: 
becoming a better me 
Yes 
Yes 
Need to send both email and text (at the same time) 
because of including web link—participants can 

 
 
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complete via smart phone or computer internet 
access. Up to 3 times for each 
B2. Complete Part II intervention: 
safe care booster 
Yes 
Yes 
Need to send both email and text (at the same time) 
because of including web link. Up to 3 times for each 
B3. Join the weekly individual 
coaching via zoom 
Yes 
Yes 
Up to 3 times 
C. 
Throughout the project 
 
 
 
C1. Fill out online survey 
Yes 
Yes 
Need to send both email and text (at the same time) 
because of including web link. Up to 3 times for each 
D. Notify Incentives  
Yes 
Yes 
Up to 3 times for each 
 
E. 
Detailed study procedures 
Recruitment and enrollment. Participants will be recruited via four approaches: (1) FaceBook, (2) 
Study Search, (3) Research Match, (4) MyChart, and (5) study flyer 
FaceBook, We will post the study flyer at FaceBook (File name: Flyer_FaceBook Add). Potential 
participants who are interested in the study will contact the study office for screening. 
Study Search. We will post the study flyer at Study Search via OSU Medical Center website (File 
name:Flyer_study search). Potential participants who are interested in the study will contact the study office for 
screening. 
Research Match. We will post the study flyer at Research Match website (File name: Flyer_Research 
Match, which describe how participants will be identified in details). The study office will contact the potential 
participants who are interested in the study.  
MyChart. We will post the study flyer at MyChart (via ‘OSU BMI’, File name: Flyer_MyChart). Upon IRB 
approval, we will submit an “honest broker data request form” followed by working with ‘OSU BMI’ to identify 
potential participants. Once potential participants who are interested in the study are identified, ‘OSU BMI’ will 
refer these potential participants to IHIS box. The trained research staff will log into IHIS to contact the 
potential participants.  
Study Flyer. We will post the study flyer in, for example, clinics, website (e.g., Craig’s list, google). We 
will also ask organizations that agree to collaborate with us to send the study flyer via email or other social 
media to their clients or customers. Potential participants who are interested in the study will contact the study 
office for screening. 
 
 
Initial Contact of Potential Participants regardless methods of recruitment. We will obtain verbal 
consent prior to screening and obtaining demographic information.  Collecting demographic data will help us 
revise or plan for recruitment strategies for a future R01. If eligible, participants will provide up to three working 
telephone numbers (at least one capable of receiving text messages), email address, and physical address as 
contact information. We will ask if we can leave a message via phone (Yes/No).  Next, the Research Staff will 
schedule a zoom meeting (individual information session, described below) within the five business days with 
the qualified participants (we will allow extension if participants indicate the time line does not work for them). 
Then, the trained research staff will send the full consent form to the participants for review (via email) prior to 
the first scheduled zoom meeting. Participants will be informed the zoom meeting will be either audio or video 
recorded per their preferences.  
 
First zoom meeting (information session lead by research staff). Participants will use their  
personal devise, for example, computer or smartphone  to join the zoom meeting, which will take up to 40 
minutes. First, the trained research staff will ask participants if they have questions and answer questions 
accordingly. Next, they will review key summary of incentive and intervention requirements (using Zoom 
“share”) with the participants and answer questions that they may have.  Also, research staff will ask the 
potential participants to think through their current and anticipated responsibilities and life situations before 
providing electronic signature (via REDCap) for participation. After that, the research staff will obtain consent 
(participants providing electronic signature via REDCap) followed by showing them how to complete the online 
survey and requirements. Then, participants will be asked to self-generate reminders to complete data 

 
 
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collection activities. Finally, participants will be informed about the purpose of the second zoom meeting. They 
will also be informed that they must complete the online survey within three weeks of the first Zoom meeting in 
order to be invited to attend the second zoom meeting.   
 
Second zoom meeting (either audio or video recorded per participant preferences. Participants will be 
enrolled. First, they will be asked to self-generate 3-5 text messages to remind them to complete the 
intervention activities and join brief individual coaching via Zoom. Next, they will receive a link to complete part 
I intervention activities, which will take up to 35 minutes to complete. Participants will use their first and last 
name, and birthday and own device (e.g., smart phone) to log into the intervention website and complete 
activities, while the research staff still on Zoom to answer women’s questions if they have.  After completion of 
the Part I intervention activities, the research staff will schedule an individual coaching session via zoom with 
the trained interventionist within the next two days. Participants will be informed that each coaching session will 
be recorded (either audio or video per their preferences). The recording will be transcribed and be analyzed to 
help us revise the individual coaching sessions for future studies. We will send a zoom link to participants to 
join the individual coaching session.  
 
Cohort retention. We will apply our previously successful retention strategies. We will allow temporary 
lapses as needed (e.g., partial data collection at T2) or extend the time window for data collection. We will 
monitor the retention rate monthly and keep retention logs by asking participants over the phone about their 
reasons for dropout and any adjustments that could keep them in the study.  
 
Intervention: A self-directed, web-based lifestyle behavior intervention (tailored to participants’ needs). 
Intervention mode. All intervention participants will receive the weekly web-based intervention for three 
weeks.  The intervention includes three topics: stress management, healthy eating, and physical activity 
(Figure 2). Intervention (long-term) goals. Participants are strongly encouraged to (1) daily manage stress 
and emotional reactions using positive strategies, (2) daily eat a diet low in fat and consume less sugary 
drinks, (3) daily eat a diet high in fruits and vegetables, and (4) walk at a brisk pace for 30 min most days a 
week.56 
 
 
Figure 2. Topics for the three-week intervention. Stress management includes three subtopics (e.g., 
better ways to handle everyday life) and 13 short-term goals (e.g., have a better relationship with family). 
Healthy eating includes four subtopics (e.g., effective ways to reduce junk food intake) and 11 short-term 
goals (e.g., daily eat less junk food and be mindful what I eat). Physical activity has one subtopic and three 
short-term goals (e.g., being more physically active outdoors).  
 
Week 1 
Week 2 
Week 3 
Weekly web (up to 40 min/week) 
Stress 
management 
Healthy eating 
Physical activity 
Weekly individual coaching via zoom 
(15 min/call, 10 calls) 
x 
x 
x 
 
 
Intervention development based on preliminary work. Informal interviews with stakeholders. We 
informally met with several clinicians who provided prenatal care to the target audience to inform our mode of 
intervention delivery. They suggested a self-directed, web-based intervention because of its easy 
implementation and future scalability to overcome clinicians’ time constraints to providing additional information 
on stress management, healthy eating and physical activity to help women manage their weight. Study one. 
We conducted seven focus group discussions with overweight or obese pregnant women (N = 96) to identify 
their critical needs in stress management, healthy eating, and physical activity. Women reported, for example, 
poor relationships with significant others, feeling emotional, eating foods for comfort, and lack of motivation to 
be physically active.123 Results of this study were used to develop the pre-written short-term goals for the 
participants (Figure 2) because most women had challenges in goal setting. Study two. Below, we present 
lessons learned from our prior NIH-NIDDK R18 intervention study of overweight or obese women of child-
bearing age124 to develop the two parts of the GOEFT intervention (Figure 3). Part I. Motivation. Lesson 
learned: Personal values and interest (autonomous motivation) motivated women to make positive lifestyle 

 
 
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behavior changes. Many women had low commitment and confidence (self-efficacy) to implement plans/steps 
to achieve personal values and make positive changes. Emotion and cognition. Lesson learned: Realizing the 
importance (i.e., the potential benefits) of accomplishing personal goals and responding to open-ended 
questions (e.g., WHAT and WHY) helped women aware of current life situations/challenges and motived them 
to make positive changes. Yet, most women faced challenges in setting goals and identifying specific steps to 
accomplish the goals. Also, many challenges (e.g., lack of willpower, time, or energy) prevented them from 
implementing their plans. Including explicit planning and (HOW) material for how to overcome challenges 
should buttress the effectiveness of the current intervention. Part II: Evaluation of goal progress with feedback. 
Lesson learned: women were often unaware what strategies helped them accomplish their goals. They often 
gave up when unaware of the progress toward their goals or the benefits received from making positive 
changes. Based on the conceptual framework (Figure 1) and results of the preliminary work, Drs. Chang (an 
expert in healthy lifestyle behavior interventions including stress management) and Wegener (Co-I, an expert 
in psychological emotion and cognition research) worked with five peers of the target audience to develop the 
proposed self-directed, web-based goal-
oriented episodic future thinking 
intervention (Figure 3). After developing 
the draft intervention, we used feedback 
from several additional peers of the target 
audience to review and finalize the 
intervention. 
 
 
Intervention 
implementation (Figure 3).  Research 
staff will provide the intervention web link 
(via text, email) and instructions on 
completing the weekly intervention 
activities online. Intervention participants 
will use their smart phone, first and last 
name, and birthday to log into the website 
to complete the Part I intervention 
activities for week one. Week one Part I 
activity will be completed during the 
second zoom meeting to increase 
participants interest in participation. Also, 
research staff will answer any questions 
that participants may have. The day of the 
week that the participants complete the 
Part I intervention activities will count as 
their weekly day one. All participants will 
be given the study office number to call for 
questions and technical problems. 
Participants will use their own device to complete Part II intervention activities for week one and the additional 
two weeks of the intervention at convenient times and locations. We will send the web link to participants 
weekly via email and text with an “intervention adherence” text message reminder (generated by the 
participants) to log in and complete the intervention activities.  
 
Part I (weekly days 1-4, 30-35 min/week): Motivation, emotion and cognition. Motivation. Participants will 
first be asked to visualize, then use a dropdown menu to select their responses (or type in a box) for the 
following: their personal values and ways to help them commit to and increase confidence in achieving their 
personal values. Emotion and cognition. First, participants will select a subtopic from the week’s designated 
topic (Figure 2) followed by selecting a pre-written short-term goal (or typing in a box) under the chosen 
subtopic that meets their need for that week’s focus.Then, they will visualize and describe WHAT the week’s 
goal is, WHY it is important, WHEN, WHERE, and with WHOM it will take place, and HOW it can be 
Figure 3.  A three-week self-directed, web-based intervention
(35-40 min/week)
Part 1 (Weekly Days 1-4: 30-35 min)
Motivation (Autonomous motivation, self-efficacy)
-Three most important personal values, ways to commit to
personal values followed by ways to boost confidence in achieving
personal values
Emotion (emotion control, stress) and Cognition (Executive
function)
-The first short-term goal, WHAT (the week's
goal),WHY(importance of the goal), WHEN and WHERE (the goal
taking place), WHO (persons involved in the goal) and HOW
(generating three steps to achieve the goal) followed by selecting
the second short-term goal and repeating five Ws and H
Motivation (self-efficacy)
 -Three daily challenges to implement the steps, three solutions to
each of the chosen challenge, and benefits of overcoming chosen
challenges.
Summary of part I
Part II (Weekly Days 5-7: 5 min)
Evaluation of Goal Process with Feedback
-Two short-term goals, helpful tips used to achieve the goals,
benefits of achieving the goals, four long-term goals followed by
personal values
Summary of part II

 
 
10 
 
accomplished, all of which enhance prospective memory, thus enabling individuals to carry out the plan to 
reach the goal.125 Related to HOW, they will be asked to view an example with three specific detailed steps to 
achieve their chosen goal. Step I. Use open-ended questions to ask themselves, thus to raise awareness of 
their current life situations/challenges (e.g., How often do I eat junk foods?). Step II. Take specific steps to 
overcome the challenges to achieve the chosen goal (e.g., pay attention to foods I eat and how much I eat). 
Step III. Record ways to reward themselves without using foods (e.g., smile and tell myself, “Wow, I am proud 
of myself of eating less junk food and being mindful what I eat, each time I follow through my plans”). After that, 
participants will visualize and describe their three steps (by typing) to accomplish the chosen goal. Next, they 
will repeat the same process for a second short-term goal for the week. Motivation. they will visualize and use 
the dropdown menus to select (or type in a box) (1) their three most important challenges (e.g., I don’t have the 
willpower) in implementing their steps to accomplish each of chosen goal for the week, (2) three potential 
solutions to overcome each chosen challenge and (3) benefits of overcoming the challenges. Phase I 
concludes with a summary of the participant’s motivation, emotion and cognition. Participants will be 
encouraged to accomplish their chosen goal within the next few days and mentally rehearse their “identified 
steps” two times daily because rehearsal increases effectiveness of goal-oriented episodic future thinking on 
the chosen goals.126  
 
 
Part II (weekly days 5-7, 5 min/week): Evaluation of goal progress with feedback. After 
implementing steps to achieve both chosen goals, they will log into the intervention website and use the 
dropdown menus to evaluate their progress on accomplishing their short-term goals, identify tips that proved 
helpful, recognize short- and long-term benefits of accomplishing the chosen goals, and rate progress on the 
four long-term intervention goals and three chosen personal values. They will receive feedback to their 
response for each evaluation component (e.g., short-term goal). Part II concludes with a summary of goal 
progress with feedback.   
 
 
Individual coaching session via Zoom (15 min/call, 10 calls). Participants will receive a call within 1-
2 days after they complete the Part I intervention activities. All coaching session will be either video or audio 
recorded (per participants’ preference) with participants’ permission. Participants will be informed that the 
recording will be transcribed and be used to refine the individual coaching session for future studies. During 
each call, the research will listen empathetically and use open-ended questions asking participants to visualize 
and describe how the week’s goals fit with their personal values, thereby supporting their motivation 
(autonomous motivation).36 Next, participants will be asked to visualize and describe how they will accomplish 
the goal(s) – what specific steps they will take. Then, the research staff will assess the specificity of the steps 
and reinforce or help modify the plans (emotion and cognition). Finally, participants will be asked to visualize 
and describe barriers to implement plans and strategies to overcome barriers. The research staff will assist 
with problem solving as needed (self-efficacy). We will keep IPC attendance records. Fidelity. Dr. Chang and 
each research will listen to a random 25% of the audio recordings monthly and use the fidelity checklist to 
assess protocol adherence, strengths, and reasons for deviations. 
 
Intervention adherence. Each week, participants will receive up to three prescheduled text reminders 
via their smart phone to engage in the week’s intervention activities (until they complete). If women have not 
completed all activities after seven days, the research staff will call and ask them to complete the activities that 
they have missed and ask reasons for nonadherence. When a woman expresses interest in quitting some 
aspects of the intervention activities, we will assess barriers to adherence, brainstorm strategies to overcome 
barriers, and offer options to reduce intervention adherence burden. We will keep intervention adherence log. 
 
F. 
Internal Validity 
 
Feasibility of recruitment, retention, intervention adherence and acceptability (Aim 1). We already plan 
to track recruitment and retention activities. Intervention adherence. The web will track and capture details 
about all activities (e.g., number of logins and amount of and type of contents used). We will also ask 
intervention participants about motivation and barriers preventing them from using the web. Acceptability. We 
will assess acceptability by asking participants to evaluate the usefulness of with each intervention component, 

 
 
11 
 
e.g., personal values, using 5 Ws and H, and rehearsal. Lessons learned and results of this aim will be used to 
refine our future R01, e.g., recruitment and intervention. 
 
Measures (See above and File Name: Study Survey. shown above). Self-reported data will be collected 
online using password-protected security-ensured Research Electronic Data Capture (REDCAP).  
 
G. 
Statistical analysis 
 
 Statistical analysis. We will use descriptive statistics to examine variable distributions, check for outliers, and 
summarize sample characteristics. Aim 1. We will (1) conduct content analysis to analyze recruitment, 
enrollment, retention and intervention adherence logs to identify successful strategies used, (2) review quality 
of steps generated to achieve goals (using a scoring system), and (3) perform descriptive statistics. We will 
also perform content analysis (for semi-structure interview questions). Aims 2, 3, and 4. Aim 5. We will 
perform descriptive analysis. We will first preform descriptive statistics. Next, we will preform mixed-effects 
linear modeling. Missing data. We will carefully examine the pattern of missing data and conduct appropriate 
multiple imputation if missing at random is indicated. The mixed-effects modeling allows for missing at random. 
If missing not at random exists, pattern mixture modeling will be used. Sensitivity analysis will evaluate the 
robustness of study findings without multiple imputation vs. those with imputation or from pattern-mixture 
modeling. 
 
Zoom IRB Boilerplate: 
Zoom is a secure, user-friendly, cloud-based enterprise videoconferencing service that Ohio State University 
implemented in 2018. Zoom is accessible to faculty and staff at all Ohio State campuses via 
https://carmenzoom.osu.edu . 
This multifaceted video and audio conferencing system supports video and audio conferencing across multiple 
platforms, including room systems, mobile devices, desktops and telephones. 
The Zoom platform at Ohio State University has two main features: Zoom meetings and Zoom webinars. 
Designed to support collaboration, Zoom meetings support up to 300 video participants. By default, any 
participant in a meeting can share their video and audio and utilize the chat feature to exchange messages 
with participants. The meeting host controls all meeting features, which include mute/unmute participants, 
screen sharing, recording options, video sharing, remote screen control and participant annotation. Annotation 
allows participants to draw and highlight on the screen share. Zoom webinar provides access for up to 300 
view-only attendees and features live question-and-answer, polling, registration and post-webinar reporting. 
Ohio State University Zoom offers both local recording and cloud recording and has a storage capacity of 270 
days for recordings. Cloud recording includes an option to produce an audio transcript for a meeting or 
webinar. The transcript is saved to the cloud as a separate .vtt text file, and the host can elect to display the 
transcript text within the video itself, similar to a closed-caption display. 
Zoom is accessed via Ohio State’s single sign-on solution, which provides an environment in which users can 
authenticate/log in at one time to a central server and connect with web-based services.  Meeting security best 
practices such as waiting lobby, inability to join before host, disabling of sharing for participants, and disabling 
annotation by participants by default have been implemented.  
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