NCT04649047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

November 24, 2020

Results QC Date

August 10, 2023

Last Update Submit

January 8, 2025

Conditions

ObesityWeight Loss

Keywords

low-income womenweight loss

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    Self-reported body weight

    baseline (T1) and 3 weeks follow up (T2)

Secondary Outcomes (13)

  • Body Mass Index

    baseline (T1) and 3 weeks follow up (T2)

  • Daily Dietary Fat Intake

    baseline (T1) and 3 weeks follow up (T2)

  • Daily Fruit and Vegetable Intake

    baseline (T1) and 3 weeks follow up (T2)

  • Frequency of Added Sugar Intake

    baseline (T1) and 3 weeks follow up (T2)

  • Daily Physical Activity (Metabolic Equivalent Task MET)

    baseline (T1) and 3 weeks follow up (T2)

  • +8 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Goal-oriented episodic future thinking

Interventions

Goal-oriented episodic future thinkingBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be a mother young children
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • weeks - 3.5 years postpartum
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr. Mei-Wei Chang
Organization
Ohio State University College of Nursing
chang.1572@osu.edu
614-247-7211

Study Officials

  • Mei-Wei Chang, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2023

Study Completion

July 1, 2023

Last Updated

January 31, 2025

Results First Posted

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)