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Support and Tracking to Achieve Results (Project STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Obesity Behavioral: ADAPTIVE Extended-Care Program Behavioral: STATIC Extended-Care Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
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
Official Title: Evaluation of an Adaptive Intervention for Weight Loss Maintenance
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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).
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116853


Contacts
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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

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Meena Shankar, MS RD CCRC    352-273-5235    mns@phhp.ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kathryn Ross, PhD, MPH University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04116853    
Other Study ID Numbers: IRB201803061 -N
R01DK119244 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Weight Loss
Weight Maintenance