Clinical trial NCT04649047: Lifestyle Behavior Weight Loss Intervention
Official title: Weight Loss Intervention for Mothers With Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: low-income women
weight loss
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions.

Detailed description: Previous research in lifestyle behavior weight loss intervention has 3 limitations. (1) Low-income overweight or obese mothers of young children have been significantly underrepresented. (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. This self-directed, web-based goal-oriented episodic future thinking intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (impulsivity). the will lead to weight loss and decrease risk of chronic conditions associated with obesity, for example, hypertension, type 2 diabetes, and cancer. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions. We will enroll 30 low-income overweight or obese mothers of young children with diverse racial and ethnic backgrounds. All participants will be assessed at baseline (T1) and immediately after the three-week intervention (T2). Specific aims are to 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.

Eligibility criteria: Inclusion Criteria:

* Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight)
* Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid)
* 6 weeks - 3.5 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:

* 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: baseline (T1) and 3 weeks follow up (T2)
Secondary outcomes:
measure: Body Mass Index
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Daily Dietary Fat Intake
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Daily Fruit and Vegetable Intake
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Frequency of Added Sugar Intake
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Daily Physical Activity (Metabolic Equivalent Task MET)
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Autonomous Motivation for Stress Management
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Autonomous Motivation for Healthy Eating
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Autonomous Motivation for Physical Activity
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in General Self-efficacy
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Healthy Eating Self-efficacy
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Physical Activity Self-efficacy
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Emotion Regulation
timeFrame: baseline (T1) and 3 weeks follow up (T2)
measure: Change in Perceived Stress
timeFrame: baseline (T1) and 3 weeks follow up (T2)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Mei-Wei Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: