Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT03139760
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2017-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
POWERSforID: Personalized Online Weight and Exercise Response System for Adults With Intellectual Disability
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POWERSforID
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: