Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
Primary Purpose
Overweight and Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss strategies
weight loss coaching sessions and email support
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Towson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
weight loss program
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change in BMI z-score among the children
Examine changes (12 week - baseline and 24 week - baseline) in BMI-z score among the children.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04697225
Brief Title
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
Official Title
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Towson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
weight loss program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
weight loss strategies
Intervention Description
Participants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress.
Intervention Type
Behavioral
Intervention Name(s)
weight loss coaching sessions and email support
Intervention Description
Participants will receive weekly coaching sessions and tailored support emails.
Primary Outcome Measure Information:
Title
Weight change among the parents at week 12
Description
Examine weight change (12 week - baseline) in kilograms (kg) among the parents in the 12-week weight loss program.
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Adherence with the scheduled weekly coaching calls
Description
Examine the parent's adherence with the weekly coaching sessions using descriptive statistics, including percent, of coaching sessions attended.
Time Frame
baseline to 12 weeks
Title
Weight change among the parents at week 24
Description
Examine weight change in kg (24 week - baseline) among the parents 12 weeks after the end of the weight loss program.
Time Frame
baseline and 24 weeks
Title
Change in BMI z-score among the children
Description
Examine changes (12 week - baseline and 24 week - baseline) in BMI-z score among the children.
Time Frame
baseline, 12, and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Jerome, PhD
Organizational Affiliation
Towson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Towson University
City
Towson
State/Province
Maryland
ZIP/Postal Code
21252
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability
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