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

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Steady Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steady Intervention<br>Participants asked to engage in Steady Intervention for 12 months | Behavioral: Steady Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention satisfaction | (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. | 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in study | 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.) | 12 months | 
| Engagement in self weighing, first quarter | 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) | months 0-3 | 
| Engagement in self weighing, final quarter | 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) | months 9-12 | 
| Portion of patients who enroll | 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) | at recruitment | 
| Representatives of those who enroll | 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) | At recruitment | 
| Use of evidence-based resources offered | 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) | 12 months | 
| Obtainment of weight data from EHR | 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) | Month 15 |