POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability

Weight Loss Clinical Trial

— POWERSforID  

Official title:

POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139760
• Other study ID #: F141230005
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

POWERSforID is a 24 week randomized control trial designed to assess the feasibility of a telehealth and coaching intervention for improving health outcomes of adults with intellectual disability. Recruitment is conducted through a disability health clinic located in Colorado Springs, CO.

Description:

POWERS (Personalized Online Weight and Exercise Response System) platform is a novel, multifocal-centered tailored intervention utilizing an innovative online tool designed to facilitate improvements in physical activity and nutritional behaviors. Aim 1 of this protocol is to customize the POWERS platform, demonstrated effective in previous research, for adults with intellectual disability (ID) and their caregivers to be referred to as POWERSforID. The POWERSforID intervention is designed to achieve weight loss and improve specific health markers while respecting and supporting the needs of the participants with ID as well as their caregivers. Aim 2 of the project is to conduct a pilot study to assess the usability and feasibility of the POWERSforID system and intervention with 5 adults with ID and their caregiver and improve the system based on pilot data. Aim 3 of the protocol is to conduct a randomized controlled trial (RCT) to examine the effect of POWERSforID on educating and coaching caregivers about nutrition and exercise and thus improving health status and reducing body weight in obese adults with ID. The investigators hypothesize that the obese participants in the intervention group (POWERSforID) will evidence significantly greater weight loss and improved health status (i.e. lower waist circumference, blood pressure, decreased body fat percentage, and improved blood lipids) compared to a control group. The investigators also hypothesize that both adults with ID and their caregivers will demonstrate improved knowledge, attitudes, and self-efficacy related to diet and exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Participants with intellectual disability (ID) who meet the following inclusion criteria are eligible to participate in the study:

• Body Mass Index > or equal to 30 kg/m2;

• Diagnosis of mild or moderate ID;

• 25 to 50 years of age;

• Medical provider approval to participate in a weight loss program;

• Has a caregiver who agrees to participate in the study and provides services 4 days a week or more to the adult with ID;

• Has access to a computer with internet throughout the week.

Exclusion Criteria:

• Currently on a weight loss program;

• Medical conditions that prevent participation as noted by the medical provider or legal guardian including heart and/or renal disease;

• Behavioral issues determined by the DDHC Behavioral Health staff;

• Unable to walk or exercise due to a mobility impairment or medical condition;

• Judged to have insufficient capacity to consent or assent as assessed using the "Supplemental Consent Document".

Related Conditions & MeSH terms

• Body Weight
• Intellectual Disability
• Motivational Interviewing
• Telehealth
• Weight Loss

Intervention

Behavioral:
• POWERSforID
Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity questionnaire	The questionnaire includes assessment of perceived barriers to physical activity and physical activity participation.	24 weeks
Other	Mood/Psychosocial questionnaire	Measured by the Glasgow depression scale, Psychosocial questionnaire for individuals with ID, scale for perceived physical and nutrition related barriers	24 weeks
Other	Dietary recall questionnaire	The questionnaire includes assessment of type of foods consumed.	24 weeks
Primary	Participation in weekly phone calls	Number of weekly intervention phone calls attended or missed	24 weeks
Primary	Number of logins to the POWERSforID website	Number of times the POWERSforID website is accessed to journal health related behaviors	24 weeks
Secondary	Weight loss	Weight change measured in kilograms	24 weeks