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

Primary Purpose

Intellectual Disability, Weight Loss, Motivational Interviewing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POWERSforID
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Intellectual Disability

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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".

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

POWERSforID

Control

Arm Description

POWERSforID intervention group

Usual clinical care

Outcomes

Primary Outcome Measures

Participation in weekly phone calls
Number of weekly intervention phone calls attended or missed
Number of logins to the POWERSforID website
Number of times the POWERSforID website is accessed to journal health related behaviors

Secondary Outcome Measures

Weight loss
Weight change measured in kilograms

Full Information

First Posted
April 22, 2017
Last Updated
November 13, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03139760
Brief Title
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
Acronym
POWERSforID
Official Title
POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Weight Loss, Motivational Interviewing, Telehealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POWERSforID
Arm Type
Experimental
Arm Description
POWERSforID intervention group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual clinical care
Intervention Type
Behavioral
Intervention Name(s)
POWERSforID
Intervention Description
Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks
Primary Outcome Measure Information:
Title
Participation in weekly phone calls
Description
Number of weekly intervention phone calls attended or missed
Time Frame
24 weeks
Title
Number of logins to the POWERSforID website
Description
Number of times the POWERSforID website is accessed to journal health related behaviors
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Weight loss
Description
Weight change measured in kilograms
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Physical activity questionnaire
Description
The questionnaire includes assessment of perceived barriers to physical activity and physical activity participation.
Time Frame
24 weeks
Title
Mood/Psychosocial questionnaire
Description
Measured by the Glasgow depression scale, Psychosocial questionnaire for individuals with ID, scale for perceived physical and nutrition related barriers
Time Frame
24 weeks
Title
Dietary recall questionnaire
Description
The questionnaire includes assessment of type of foods consumed.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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".
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Rimmer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35292
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29058620
Citation
Neumeier WH, Guerra N, Thirumalai M, Geer B, Ervin D, Rimmer JH. POWERS forID: Personalized Online Weight and Exercise Response System for Individuals with Intellectual Disability: study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):487. doi: 10.1186/s13063-017-2239-2.
Results Reference
derived

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

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