Clinical trial NCT05049005: Alternative Dietary Approaches Online to Promote Tracking
Official title: Dietary Approaches for Improving Engagement, Diet Quality, and Weight Loss in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Quality
Weight Loss
Keywords: Adherence, diet tracking, diet goals
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity.

Participants: Young adult men and women who are between the ages of 18-35 years (N=75) and who currently have overweight or obesity (BMI between 25 and 50 kg/m\^2).

Procedures (methods): This is a randomized controlled trial comparing the efficacy of two Internet-based dietary interventions among 75 young adult men and women who currently have overweight or obesity. Both interventions will use simplified monitoring of dietary intake using an approach based on the Traffic Light Diet. One intervention will target a reduction in intake of red foods (high-calorie, high-fat foods) and tracking of red foods in the study website. The other intervention will target an increase in intake of green foods (low-calorie, healthy foods) and tracking of green foods in the study website. Components of both interventions include (1) personalized goals for red/green food intake, (2) weekly tailored feedback, and (3) weekly lessons delivered via smartphone.

Detailed description: The primary objective of the study is to test two approaches for dietary self-monitoring among young adults with overweight/obesity. Thus, all participants will receive an Internet-based dietary intervention that includes evidence-based lessons focused on dietary change, behavioral skills training, and frequent weighing. The only difference between the two groups will be the types of foods participants are instructed to self-monitor and the dietary goals participants are given. Young adult men and women (N=75) will be randomly assigned, with equal probability, to one of two groups:

1. Red food reduction intervention (RED FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily red food monitoring using a mobile-optimized study website.
2. Green food promotion intervention (GREEN FOOD): An Internet-based dietary intervention delivered via REDCap; weekly self-report of weight and daily green food monitoring using a mobile-optimized study website.

During the 3-month Internet-based dietary intervention, participants will receive an email at the beginning of each week with a link to a REDCap page that will ask them to self-report their weight. They will then be directed via REDCap to their tailored feedback summaries based on their self-reported weight data and the dietary monitoring data that is pulled from the study website. After reading their feedback, participants will be directed to a weekly lesson in REDCap. Participants will be encouraged to login to the study website every day to self-monitor red or green foods, depending on their intervention group. Participants will receive a unique username and password to login to the study website. Each intervention component is described in more detail below.

Intervention Components:

Participant goals: Participants will be assigned a dietary goal based on their baseline weight. Participants will be able to view their daily dietary goal (number of red foods per day in RED FOOD and number of green foods per day in GREEN FOOD) on the study website. Participants' dietary goals will be based on their intervention group. Participants will not receive specific goals for weighing or physical activity. However, all participants will be recommended to weigh frequently throughout the week, as research has shown this is best for successful weight loss. Participants will self-report their weight online via REDCap once per week.

Weekly feedback: Participants will receive tailored feedback summaries via REDCap weekly. Participants will receive an email to self-report their weight in REDCap, after which they will be directed to their feedback page. The feedback message will include feedback based on participants' number of days tracking diet, progress toward their dietary goal, and self-reported weight for the week.

Lessons: Lessons will be updated weekly and made available in REDCap. Lesson content will focus on specific areas of diet or eating behavior which participants could focus on changing over the next week. Behavioral topics typically included in behavioral weight control programs will be incorporated into the lessons including problem solving, planning ahead, and stimulus control. Participants will be directed to the REDCap lesson after reviewing their weekly feedback message.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 25 and 50 kg/m\^2
* English-speaking and writing
* Own a smartphone with an active data and text messaging plan
* Own a bathroom scale or willing to purchase a bathroom scale prior to the study start date
* Willing to be randomized to either group

Exclusion Criteria:

* Type I or Type 2 diabetes
* Currently participating in another nutrition or weight loss program
* Lost 10 or more pounds (and kept it off) in the last 6 months
* Currently taking weight loss medications
* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant in the next 6 months
* Serious current physical disease (i.e. heart disease, stroke, cancer, or renal disease) for which physician supervision of diet and exercise prescription is needed
* Physical problems that limit the ability to exercise daily
* History of clinically diagnosed eating disorder
* Report a past diagnosis of or current symptoms of alcohol or substance dependence
* Diagnosis of schizophrenia or bipolar disorder
* Hospitalization for a psychiatric diagnosis within the last year
* Currently living with another study participant

Primary outcomes:
measure: Adherence to dietary tracking
timeFrame: 3 months
measure: Adherence to dietary goals
timeFrame: 3 months
Secondary outcomes:
measure: Percent weight loss
timeFrame: 3 months
measure: Change in Dietary intake
timeFrame: Baseline, Month 3
measure: Change in Diet quality
timeFrame: Baseline, Month 3
Other outcomes:
measure: Change in Restraint, Disinhibition, Hunger
timeFrame: Baseline, Month 3
measure: Change in Self-Regulation (eating behaviors)
timeFrame: Baseline, Month 3
measure: Change in Self-Regulation (global)
timeFrame: Baseline, Month 3
measure: Change in Self-Efficacy (diet)
timeFrame: Baseline, Month 3
Locations:
city: Chapel Hill
country: United States
facility: UNC Weight Research Program
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Julianne M Power, MS
role: PRINCIPAL_INVESTIGATOR
References: