Lifestyle Behavior Weight Loss Intervention

NCT ID: NCT04649047

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-07-01

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity

Group Type: EXPERIMENTAL

Goal-oriented episodic future thinking

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Mei-Wei Chang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei-Wei Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2020B0322

Identifier Type: -

Identifier Source: org_study_id