Lifestyle Behavior Weight Loss Intervention

Obesity Clinical Trial

Official title:

Weight Loss Intervention for Mothers With Young Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04649047
• Other study ID #: 2020B0322
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• Goal-oriented episodic future thinking
All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Self-reported body weight	baseline (T1) and 3 weeks follow up (T2)
Secondary	Waist circumference	Self-reported pants size will be used to measure waist circumference. Participants will report their current pants size. Values are: 00-0 = extra small, 2-4 = small, 6-8 = medium, 10-12 = large,14-16 = extra large, 18-20 = 2XL, 22-24 =3XL. Higher scores indicate higher waist circumference.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in dietary fat intake	The NCI brief dietary fat intake survey (16 items) will be used to measure dietary fat intake. Participants will be asked to report the frequency of each specific food that they eat over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in fruit and vegetable intake	The NCI brief fruit and vegetable intake survey (9 items) will be used to measure fruit and vegetable intake. Participants will be asked to report frequency of each specific fruit and vegetable that they eat over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent fruit and vegetable intake.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in added sugar intake	The NCI five-factor screener (4 items) will be used to measure added sugar intake. Participants will be asked to report frequency of each specific soda beverages that they drink over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent added sugar intake.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in physical activity	The International Physical Activity Questionnaire Short Form (7 items) will be used to measure physical activity. Participants will be asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities that they did in the past 7 days. Higher scores indicate more physical activity.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in autonomous motivation for stress management	The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for stress management. Participants will be asked to report why they manage stress.; Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for stress management.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in autonomous motivation for healthy eating	The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for healthy eating. Participants will be asked to report why they eat healthier foods.; Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for healthy eating.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in autonomous motivation for physical activity	The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for physical activity. Participants will be asked to report why they want to be physically active. Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for physical activity.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in coping self-efficacy	Survey for coping self-efficacy (10 items) will be used to measure coping self-efficacy. Participants will be asked to report their confidence in coping stress. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher coping self-efficacy.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in healthy eating self-efficacy	Survey for healthy eating self-efficacy (8 items) will be used to measure healthy eating self-efficacy. Participants will be asked to report their confidence in eating healthier. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident.; Higher scores indicate higher healthy eating self-efficacy.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in physical activity self-efficacy	Survey for healthy eating self-efficacy (10 items) will be used to measure physical activity self-efficacy. Participants will be asked to report their confidence in more physically active. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher physical activity self-efficacy.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in social support for stress management	A survey (6 items) will be used to measure social support for stress management. The survey assess how often participants asking for family members, friends, co-worker or other people for support when they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for stress management.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in social support for healthy eating	A survey (5 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for healthy eating.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in social support for physical activity	A survey (4 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for physical activity.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in emotion regulation	Emotion Regulation Questionnaire (10 items) will be used to assess emotion regulation. This questionnaire assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 sub scales: reappraisal (6 items) and suppression (4 items). Values are 1 = strongly disagree, 2 = mostly disagree, 3 =somewhat disagree, 4= neither agree or disagree, 5 = somewhat agree, 6 = mostly agree, 7 = strongly agree. Higher scores indicate higher reappraisal or suppression.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in perceived stress	The perceived stress scale (10 items) will be used to measure perceived stress. This survey measures the degree to which situations in one's life are appraised as stressful.; Values are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4= very often Higher scores indicate higher levels of perceived stress.	baseline (T1) and 3 weeks follow up (T2)
Secondary	Change in impulsiveness	The Barratt Impulsiveness scale (30 items) will be used to measure impulsiveness. This survey measures the degree to which situations in one's life are appraised as stressful.; Values are 1 = never, 2 = rarely, 3 = almost always, 4= always. Higher scores indicate less impulsiveness.	baseline (T1) and 3 weeks follow up (T2)