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Completed

NCT Number: NCT04751656

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

The goal of this pilot trial is to pilot test an intervention to help prevent weight gain or produce weight loss among adults with obesity. Participants are asked to self-weigh on a smart scale for one year. Feasibility and acceptability outcomes are examined.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STEADY intervention

Behavioral

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 outcomes

  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 reported here is response to item "overall, I am satisfied with this program." with response options 1-5, 1-strongly disagree, 3-neither agree nor disagree, and 5-strongly agree.

Secondary outcomes

  1. Retention in Study

    Time frame: 12 months

    Percent 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

    days/week in which weight was registered

  3. Engagement in Self Weighing, Final Quarter

    Time frame: months 9-12

    mean days per week in which weight was registered

  4. Percent of Patients Who Enroll

    Time frame: at recruitment

    Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.

  5. Representatives of Those Who Enroll

    Time frame: At recruitment

    Percent of those participants who enroll who are male.

  6. Use of Evidence-based Resources Offered

    Time frame: 12 months

    Percent of patients who initiate use of comprehensive weight loss program

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment

Acronym: STEADY

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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