Clinical Trials Directory

Trials / Completed

CompletedNCT04649047

Lifestyle Behavior Weight Loss Intervention

Weight Loss Intervention for Mothers With Young Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Ohio State University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGoal-oriented episodic future thinkingAll participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity

Timeline

Start date
2021-02-01
Primary completion
2023-02-01
Completion
2023-07-01
First posted
2020-12-02
Last updated
2025-01-31
Results posted
2025-01-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04649047. Inclusion in this directory is not an endorsement.