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Support and Tracking to Achieve Results (Project STAR)

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ClinicalTrials.gov Identifier: NCT04116853
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE October 3, 2019
First Posted Date  ICMJE October 7, 2019
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE October 17, 2019
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
Change in weight regain of the ADAPTIVE group compared to the STATIC group [ Time Frame: Baseline; Month 4; Month 12; Month 24 ]
Participant body weight will be measured at the screening visit as well as all assessment visits by trained research staff using calibrated Tanita digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04116853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Support and Tracking to Achieve Results (Project STAR)
Official Title  ICMJE Evaluation of an Adaptive Intervention for Weight Loss Maintenance
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
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Outcomes Assessor)
Masking Description:
Assessments will be conducted by trained study staff members masked to maintenance condition.
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: ADAPTIVE Extended-Care Program
    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.
  • Behavioral: STATIC Extended-Care Program
    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 Arms  ICMJE
  • 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.
    Intervention: Behavioral: ADAPTIVE Extended-Care Program
  • 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).
    Intervention: Behavioral: STATIC Extended-Care Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2019)
430
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathryn Ross, PhD, MPH 352-273-5235 kmross@phhp.ufl.edu
Contact: Meena Shankar, MS, RD, CCRC 352-273-5235 mns@phhp.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04116853
Other Study ID Numbers  ICMJE IRB201803061 -N
R01DK119244 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Kathryn Ross, PhD, MPH University of Florida
PRS Account University of Florida
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP