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OpenTrials
Completed

NCT Number: NCT04697225

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Towson University

Towson, Maryland, 21252, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss strategies

Behavioral

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

Behavioral

Participants will receive weekly coaching sessions and tailored support emails.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Towson University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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