Support and Tracking to Achieve Results (Project STAR)

University of Florida

Status: Completed

Conditions: Obesity

Treatments: Behavioral: STATIC Extended-Care Program; Behavioral: ADAPTIVE Extended-Care Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04116853

IRB201803061 -N

R01DK119244 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance.

The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at "high risk" for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.

Enrollment: 255 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI 30.0-45.0 kg/m2
• Own a smartphone [Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)] with a cellular and data plan
• Weight ≤ 396 pounds (due to scale limit)
• Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
• Completion of baseline assessment measures

Exclusion criteria

• History of bariatric surgery
• Current use of weight loss medications
• Weight loss of ≥ 10 lb in prior 6 months
• Physical limitations that prevent walking ¼ mile without stopping
• Use of a pacemaker
• Currently pregnant
• Currently breastfeeding
• Less than 1 year post-partum
• Plans to become pregnant within the study period
• Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with type 2 diabetes, hypertension, or has a history of coronary heart disease
• More than one participant per household (enrollment limited to one participant per household)
• Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, or plans to relocate during the study period)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

255 participants in 2 patient groups

ADAPTIVE Extended-Care Group

Experimental group

Description:

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.

Treatment:

Behavioral: ADAPTIVE Extended-Care Program

STATIC Extended-Care Group

Active Comparator group

Description:

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).

Treatment:

Behavioral: STATIC Extended-Care Program