NCT03291509

Remote Delivery of Weight Management for Adults With IDD

Completed NA Results posted Last updated 7 March 2023

What this trial tests

NA trial testing Video Conference Meetings in Obesity in 120 participants. Completed in 14 August 2022.

Timeline

21 February 2018

Primary endpoint
16 March 2021

14 August 2022

Quick facts

Lead sponsor	University of Kansas Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	21 February 2018
Primary completion	16 March 2021
Estimated completion	14 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Video Conference Meetings
• In-person Meetings
• Enhanced Stop Light Diet
• Physical Activity

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Kansas Medical Center

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Weight (kg) Primary · Change from Baseline to Month 6

Change in weight (kg) from baseline to 6 months

Group	Value	95% CI
Face to Face	-2.1	± 6.7
Remote Delivery	-4.9	± 7.8

Change in Weight (kg) Secondary · Change from Baseline to Month 24

Change in weight across the 24 month study

Group	Value	95% CI
Face to Face	-2.3	± 10.1
Remote Delivery	-4.5	± 10.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Face to Face

Serious: 1/60 (2%)

Deaths: 1/60

Remote Delivery

Serious: 1/60 (2%)

Deaths: 0/60

Serious adverse events (2 terms)

Reaction	System	Face to Face	Remote Delivery
Death	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac Arrest	Cardiac disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Face to Face	Remote Delivery
Broken Bone	Musculoskeletal and connective tissue disorders	—	—
Muscle Strain	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Death, Cardiac Arrest.

Data from ClinicalTrials.gov NCT03291509 adverse events section.

Sponsor's own description

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial.
   Ptomey LT, Washburn RA, Sherman JR, Mayo MS, et al · · 2024 · cited 3× · PMID 38272776 · DOI 10.1016/j.dhjo.2024.101587