NCT02708121

Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

Completed NA Results posted Last updated 25 June 2019

What this trial tests

NA trial testing Motivational Intervention in Obesity in 66 participants. Completed in 23 February 2018.

Timeline

3 March 2017

Primary endpoint
23 February 2018

23 February 2018

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	66
Start date	3 March 2017
Primary completion	23 February 2018
Estimated completion	23 February 2018
Sites	1 location across United States

Drugs / interventions tested

• Motivational Intervention
• Comparator Intervention

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Florida

Who can join

Adults 18 to 75, 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.

Number of Participants Attending 6 Month Follow-up Appointment Primary · 6 months

Count of enrolled participants who attend 6 month follow-up appointment

Group	Value	95% CI
Mobilization Tool Arm	22
Comparator Tool Arm	19

Intervention Acceptability (Acceptability Outcome) Secondary · 1 month

Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11.

Item 1: Enjoyed

Group	Value	95% CI
Mobilization Tool Arm	4.15	± 0.67

Item 2: Learning

Group	Value	95% CI
Mobilization Tool Arm	4.05	± 0.83

Item 3: Easy to use

Group	Value	95% CI
Mobilization Tool Arm	4.25	± 0.72

Item 4: Secure

Group	Value	95% CI
Mobilization Tool Arm	4.30	± 0.73

Item 5: Interested

Group	Value	95% CI
Mobilization Tool Arm	4.10	± 0.72

Item 6: Trustworthy

Group	Value	95% CI
Mobilization Tool Arm	4.15	± 0.75

Item 7: Enough time

Group	Value	95% CI
Mobilization Tool Arm	4.15	± 0.75

Item 8: Easy to understand

Group	Value	95% CI
Mobilization Tool Arm	4.35	± 0.59

Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report Secondary · 6 months

Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one)

Treatment initiation, program data

Group	Value	95% CI
Mobilization Tool Arm	20
Comparator Tool Arm	8

Treatment initiation, self-report

Group	Value	95% CI
Mobilization Tool Arm	14
Comparator Tool Arm	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months (study period). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mobilization Tool Arm

Serious: 1/34 (3%)

Deaths: 0/34

Comparator Tool Arm

Serious: 0/26 (0%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	Mobilization Tool Arm	Comparator Tool Arm
Hospitalization	Gastrointestinal disorders	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT02708121 adverse events section.

Sponsor's own description

This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.

Publications & conference data

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

1. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial.
   McVay MA, Yancy WS, Bennett GG, Levine E, et al · · 2021 · cited 6× · PMID 31586443 · DOI 10.1093/tbm/ibz143