Support and Tracking to Achieve Results (Project STAR)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04116853
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ADAPTIVE Extended-Care Program — BEHAVIORAL
    Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
  • STATIC Extended-Care Program — BEHAVIORAL
    Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.

Study Details

The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions

Key Dates

Start date
Oct 17, 2019
Status verified
Apr 2025
Primary completion
Nov 5, 2024
Completion
Nov 5, 2024

Study Design

Enrollment
255 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADAPTIVE Extended-Care Group
    Participants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at "high risk" for weight regain or 2) the participant self-initiates a request for a session.
  • Active Comparator: STATIC Extended-Care Group
    Participants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs).

Primary Outcome Measure

Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss [ Time Frame: Baseline; Month 4; Month 12; Month 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610-

Find similar trials in Gainesville, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Florida· Gainesville, FL

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