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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697225
• Other study ID #: 1181
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: Towson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.
• weight loss coaching sessions and email support
Participants will receive weekly coaching sessions and tailored support emails.

Locations

Country	Name	City	State
United States	Towson University	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Towson University

Country where clinical trial is conducted

United States, 

Outcome

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