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

Sponsor
Towson University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04697225
Collaborator
(none)
12
1
1
23.9
0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: weight loss strategies
  • Behavioral: weight loss coaching sessions and email support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weight change among the parents at week 12 [baseline and 12 weeks]

    Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.

Secondary Outcome Measures

  1. Adherence with the scheduled weekly coaching calls [baseline to 12 weeks]

    Examine the parent's adherence with the weekly coaching sessions using descriptive statistics, including percent, of coaching sessions attended.

  2. Weight change among the parents at week 24 [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.

  3. Change in BMI z-score among the children [baseline, 12, and 24 weeks]

    Examine changes (12 week - baseline and 24 week - baseline) in BMI-z score among the children.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Towson University Towson Maryland United States 21252

Sponsors and Collaborators

  • Towson University

Investigators

  • Principal Investigator: Gerald Jerome, PhD, Towson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Towson University
ClinicalTrials.gov Identifier:
NCT04697225
Other Study ID Numbers:
  • 1181
First Posted:
Jan 6, 2021
Last Update Posted:
Jun 13, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022