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

Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Steady Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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 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.	12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in Study	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.)	12 months
Engagement in Self Weighing, First Quarter	days/week in which weight was registered	months 0-3
Engagement in Self Weighing, Final Quarter	mean days per week in which weight was registered	months 9-12
Percent of Patients Who Enroll	Percent of those who are eligible who are interested in and enroll in the Steady Intervention out of those who complete the screening measure.	at recruitment
Representatives of Those Who Enroll	Percent of those participants who enroll who are male.	At recruitment
Use of Evidence-based Resources Offered	Percent of patients who initiate use of comprehensive weight loss program	12 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Megan McVay, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight; Weight Gain
• Other Study ID Numbers: IRB202001935-N-R; 5R03HL154272-02 (U.S. NIH Grant/Contract); AWD08696 (Other Identifier: UFIRST Awards)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be prepared according to requirements for NHLBI data repository datasets and will be stored in the NHLBI data repository.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Consistent with NHLBI repository guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No