Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability

November 20, 2023 updated by: Towson University
The objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. It is a first step towards a parent-only approach to promote healthier weight among children with a disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21252
        • Towson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Parent

  • age ≥18
  • English speaking
  • completion of screening and baseline data collection
  • BMI ≥ 25 and weight < 300lbs (weight limit due to scale limitations)
  • willing to lose weight through physical activity, weight tracking and decreased caloric intake
  • willing to make changes at home to facilitate a healthy weight
  • willing to complete 12 weekly weight loss video coaching sessions (20 minutes/session)
  • willing to use Skype, FaceTime, Zoom, or WebEx for regular intervention contact
  • Internet/ cellular plan that is sufficient for weekly program video conferencing
  • willing to use the study scale with cellular technology to report weights at baseline, 12 weeks, and 24 weeks.
  • willing to use the study scale with cellular technology at least weekly during the study (12 weeks)
  • completion of screening and baseline data collection

Child

  • age 8-18
  • has a disability
  • assent is required if the child is capable and willing to have height and weight taken by the parent at baseline, 12 weeks, and 24 weeks.

Exclusion Criteria:

  • parent or child: previously diagnosed eating disorder, or treatment for an eating disorder
  • parent: currently pregnant or plan to get pregnant in the next 6 months
  • parent: planned weight loss surgery or procedure in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: weight loss program
Behavioral: weight loss strategies
Participants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress.
Behavioral: weight loss coaching sessions and email support
Participants will receive weekly coaching sessions and tailored support emails.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change among the parents at week 12
Time Frame: baseline and 12 weeks
Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence with the scheduled weekly coaching calls
Time Frame: baseline to 12 weeks
Examine the parent's adherence with the weekly coaching sessions using descriptive statistics, including percent, of coaching sessions attended.
baseline to 12 weeks
Weight change among the parents at week 24
Time Frame: baseline and 24 weeks
Examine weight change in kg (24 week - baseline) among the parents 12 weeks after the end of the weight loss program.
baseline and 24 weeks
Change in BMI z-score among the children
Time Frame: baseline, 12, and 24 weeks
Examine changes (12 week - baseline and 24 week - baseline) in BMI-z score among the children.
baseline, 12, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Towson University

Investigators

  • Principal Investigator: Gerald Jerome, PhD, Towson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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