Support and Tracking to Achieve Results (Project STAR)

NCT04116853 | Completed Results

• 2 other identifiers: IRB201803061 -NR01DK119244
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Weight Loss; Weight Maintenance

Outcome Measures

Primary Outcomes (1)

• Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss

  Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight loss (i.e., weight change from baseline to Month 4). Thus, although the outcome (weight) is assessed at each time point, the primary outcome is only a single comparison. Weight in kg at each time point are reported below (using intent-to-treat analyses, with multiple imputation used to handle missing data) along with the difference in weight change from Month 4 to Month 24 by group (Month 24 weight - Month 4 weight), controlling for initial weight loss (Month 4 weight - Baseline weight).

  Baseline; Month 4; Month 12; Month 24

Study Arms (2)

ADAPTIVE Extended-Care Group

EXPERIMENTAL

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.

Behavioral: ADAPTIVE Extended-Care Program

STATIC Extended-Care Group

ACTIVE COMPARATOR

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).

Behavioral: STATIC Extended-Care Program

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.

ADAPTIVE Extended-Care Group

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.

STATIC Extended-Care Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (6)

• Ross KM, Swanson TN, Arroyo KM, Shetty A, Shankar MN, Krukowski RA. Within-week and within-year patterns in self-monitoring of dietary intake in adults with obesity participating in a behavioral weight loss program. Health Psychol Behav Med. 2025 Apr 2;13(1):2485476. doi: 10.1080/21642850.2025.2485476. eCollection 2025.

  PMID: 40182625 RESULT

• Shetty A, Ross KM. Associations Between Body Mass Index, Body Image Satisfaction, and Self-Weighing During a Behavioral Weight Loss Program. Obes Sci Pract. 2025 May 3;11(3):e70074. doi: 10.1002/osp4.70074. eCollection 2025 Jun.

  PMID: 40321456 RESULT

• Swanson TN, Bauman V, Ross KM. Associations between chronotype, weight loss, and adherence to caloric intake and physical activity goals during a behavioral weight loss intervention. J Behav Med. 2025 Aug;48(4):722-729. doi: 10.1007/s10865-025-00573-y. Epub 2025 May 7.

  PMID: 40335844 RESULT

• Ross KM, Carpenter CA, Arroyo KM, Shankar MN, Yi F, Qiu P, Anthony L, Ruiz J, Perri MG. Impact of transition from face-to-face to telehealth on behavioral obesity treatment during the COVID-19 pandemic. Obesity (Silver Spring). 2022 Apr;30(4):858-863. doi: 10.1002/oby.23383. Epub 2022 Mar 11.

  PMID: 35037410 RESULT

• Ross KM, Shankar MN, Qiu P, Tian Z, Ruiz J, Anthony L, Perri MG. Adaptive vs Monthly Support for Weight-Loss Maintenance: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532681. doi: 10.1001/jamanetworkopen.2025.32681.

  PMID: 40982283 RESULT

• Ross KM, Shankar MN, Qiu P, Tian Z, Swanson TN, Shetty A, Ruiz J, Anthony L, Perri MG. Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance. Contemp Clin Trials. 2024 Nov;146:107707. doi: 10.1016/j.cct.2024.107707. Epub 2024 Oct 9.

  PMID: 39384066 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Kathryn Ross, PhD MPH
• Organization: Advocate Aurora Research Institute

Kathryn.Ross@aah.org

414-647-6312

Study Officials

• Kathryn Ross, PhD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by trained study staff members masked to maintenance condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All randomized participants will receive extended-care intervention delivered via phone; however, the frequency/timing of these calls will vary between the ADAPTIVE and STATIC conditions.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 17, 2019
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: November 5, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)