NCT03139760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

April 22, 2017

Last Update Submit

November 13, 2018

Conditions

Intellectual DisabilityWeight LossMotivational InterviewingTelehealth

Outcome Measures

Primary Outcomes (2)

  • Participation in weekly phone calls

    Number of weekly intervention phone calls attended or missed

    24 weeks

  • Number of logins to the POWERSforID website

    Number of times the POWERSforID website is accessed to journal health related behaviors

    24 weeks

Secondary Outcomes (1)

  • Weight loss

    24 weeks

Other Outcomes (3)

  • Physical activity questionnaire

    24 weeks

  • Mood/Psychosocial questionnaire

    24 weeks

  • Dietary recall questionnaire

    24 weeks

Study Arms (2)

POWERSforID

EXPERIMENTAL

POWERSforID intervention group

Behavioral: POWERSforID

Control

NO INTERVENTION

Usual clinical care

Interventions

POWERSforIDBEHAVIORAL

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

POWERSforID

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index \> or equal to 30 kg/m2;
  • Diagnosis of mild or moderate ID;
  • 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.

You may not qualify if:

  • 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".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35292, United States

Location

Related Publications (1)

  • 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.

    PMID: 29058620DERIVED

MeSH Terms

Conditions

Intellectual DisabilityWeight Loss

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBody Weight ChangesBody Weight

Study Officials

  • James Rimmer, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2017

First Posted

May 4, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)