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

NCT04751656 | Completed Results

• 3 other identifiers: IRB202001935-N-R5R03HL154272-02AWD08696
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Retention in Study

  12 months

• Engagement in Self Weighing, First Quarter

  months 0-3

• Engagement in Self Weighing, Final Quarter

  months 9-12

• Percent of Patients Who Enroll

  at recruitment

• Representatives of Those Who Enroll

  At recruitment

Study Arms (1)

Steady Intervention

EXPERIMENTAL

Participants asked to engage in Steady Intervention for 12 months

Behavioral: Steady Intervention

Interventions

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.

Steady Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Megan McVay
• Organization: University of Florida

megan.mcvay@ufl.edu

352-294-1638

Study Officials

• Megan McVay, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm trial

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: April 16, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)