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

Overweight and Obesity Clinical Trial

— STEADY  

Official title:

Preventing Weight Gain Among Those Who Decline Behavioral Weight Loss Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751656
• Other study ID #: IRB202001935-N-R
• Secondary ID: 5R03HL154272-02A
• Status: Completed
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Gain
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Engagement in Self Weighing, First Quarter	days/week in which weight was registered	months 0-3
Secondary	Engagement in Self Weighing, Final Quarter	mean days per week in which weight was registered	months 9-12
Secondary	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
Secondary	Representatives of Those Who Enroll	Percent of those participants who enroll who are male.	At recruitment
Secondary	Use of Evidence-based Resources Offered	Percent of patients who initiate use of comprehensive weight loss program	12 months