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Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment (STEADY) (STEADY)

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: NCT04751656
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : September 16, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
To prevent weight gain while overcoming these common barriers to engaging in weight management interventions, we propose an intervention that prescribes self-weighing but does not prescribe changes in diet or physical activity behaviors or require attendance at didactic-focused meetings. The potential of self-weighing to promote weight management is supported both by self-regulatory theory and empirical research. Promoting self-weighing may activate participants' self-regulatory skills, leading to spontaneous decisions to reduce calorie intake or increase physical activity, thus preventing further weight gain. The proposed intervention will also provide individuals with text message-based feedback to promote continued self-weighing and to motivate engagement with evidence-based resources for weight management at a time when they may be more open to using these resources-e.g., after experiencing a small weight gain. The current proposal will investigate the feasibility and acceptability of this low burden self-weighing intervention in order to prepare for a fully-powered, pragmatic randomized controlled trial. We will enroll 40 patients with either obesity or overweight with a weight-related comorbidity and who have declined to participate in a comprehensive behavioral weight management program. Participants will be asked to weigh themselves daily via a "smart" scale that transmits weight data directly to the study team via the cellular network. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources. In a single-arm design, all enrolled participants will receive the intervention for 12 months and will complete assessments at 3 and 12 months to assess feasibility and acceptability of the intervention and trial design, while weight will be obtained from participants' Electronic Health Records (EHR). We will evaluate our success in meeting pre-specified metrics for trial feasibility and intervention acceptability outcomes, including intervention enrollment, intervention satisfaction, and obtainment of weight data abstracted from participants' EHRs. We will also evaluate the success of the intervention in promoting regular self-weighing and use of evidence-based weight management resources.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Steady Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment
Actual Study Start Date : April 16, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Steady Intervention
Participants asked to engage in Steady Intervention for 12 months
Behavioral: Steady Intervention
Participants will be asked to weigh themselves daily via a "smart" scale that transmits weight data directly to the study team via the cellular network for 12 months. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources.




Primary Outcome Measures :
  1. Intervention satisfaction [ Time Frame: 12 months. ]

    (NOTE: this is a pilot study and there is not a true primary outcome. There are several descriptive outcomes that will inform our decision to proceed to a traditional, fully powered clincial trial).

    Intervention satisfaction will be measured on a on 12-item study specific questionnaire asking about satisfaction with various aspects of program, such as usability, helpfulness, and if they would recommend program to a friend. This is a study specific measure without a measure name. Items will be presented separately and not combined for a total scale.

    Descriptive data (means, SD, range) will be presented on each item. For some items, higher numbers is better and for other items lower numbers are better.



Secondary Outcome Measures :
  1. Retention in study [ Time Frame: 12 months ]
    Portion of participants completing 12 month survey. (There is no measurement used for this. It is based on the portion of patients who complete the 12 month survey.)

  2. Engagement in self weighing, first quarter [ Time Frame: months 0-3 ]
    Portion of participants weighing themselves on home smart scale 6 or more days per week for 9 or more weeks in first quarter of intervention. (There is no measurement used for this, it is based on the portion of participants who meet the specified threshold of self-weighing based on data obtained from the smart scale)

  3. Engagement in self weighing, final quarter [ Time Frame: months 9-12 ]
    Portion of participants weighing themselves on home smart scale 6 or more days for 9 or more weeks in final quarter of intervention. (There is no measurement used for this, it is based on the portion of participants who meet the specified threshold of self-weighing based on data obtained from the smart scale)

  4. Portion of patients who enroll [ Time Frame: at recruitment ]
    Portion of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure. (There is no measurement used for this, it is based on the portion of participants who enroll)

  5. Representatives of those who enroll [ Time Frame: At recruitment ]
    Portion who enroll who are male, Black/African American, and Latino.(There is no measurement used for this, it is based on the frequency of participants who identify with these races/ethnicity)

  6. Use of evidence-based resources offered [ Time Frame: 12 months ]
    Portion of those offered additional resources as part of the intervention who view it and portion who initiate use of resources. (this is a behavioral outcome, based on portion who view and use resources)

  7. Obtainment of weight data from EHR [ Time Frame: Month 15 ]
    Portion of those who enroll who have at least one weight measure in EHR between months 9-15 (there is no measure for this, it is based on portion who have a weight in their EHR)



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:

  • Age 18-70
  • Body weight recorded in EHR in the prior month from a primary care setting.
  • Last BMI in EHR either ≥30 kg/m2 or between 25.0-29.9 kg/m2 with documented weight-related comorbidity (hypertension, type II diabetes, pre-diabetes, dyslipidemia, sleep apnea).
  • Weight ≤ 375 lbs.
  • Self-report sending and receiving at least one text message per month for past 6 months.
  • Not currently enrolled in comprehensive behavioral weight loss treatment.
  • Respond "no" to question asking if they would like to enroll in a comprehensive weight loss program in the next month
  • Has not engaged in self-weighing ≥ 5 times per week on average over prior month.
  • Not pregnant, breastfeeding, or planning to become pregnant in next 6 months.
  • Not currently undergoing radiation or chemotherapy for cancer.
  • No history of eating disorders.
  • Interested in enrolling in low-burden self-weighing intervention.
  • Able to read and understand English without help

Exclusion criteria:

  • History of Congestive Heart Failure or heart attack in past 6 months.
  • Planning to move out of the region in the following 12 months
  • Answer incorrectly on an attention check/ validation survey item

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): NCT04751656


Contacts
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Contact: Megan McVay, PhD 352-294-7029 megan.mcvay@ufl.edu

Locations
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United States, Florida
UF Health at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Megan McVay, PhD    352-294-1638    megan.mcvay@ufl.edu   
Principal Investigator: Megan McVay, PhD         
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Megan McVay, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04751656    
Other Study ID Numbers: IRB202001935-N-R
5R03HL154272-02 ( U.S. NIH Grant/Contract )
AWD08696 ( Other Identifier: UFIRST Awards )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset will be prepared according to requirements for NHLBI data repository datasets and will be stored in the NHLBI data repository.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Per guidelines for sharing in the NHLBI repository, the data set will be submitted to the NHLBI program officer as soon as it is prepared, and no later than 3 years after the end of clinical activities.
Access Criteria: Consistent with NHLBI repository guidelines.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Weight Loss
Weight Gain
Body Weight
Body Weight Changes