Daily Self-Weighing for Obesity Management in Primary Care (SWOP)

Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Daily Self-Weighing

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy E Dobelstein; Phone Number: 2059751059; Email: adobelst@uabmc.edu
• Study Contact Backup: Name: Gareth R Dutton, PhD; Phone Number: 2059346876; Email: gdutton@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 19-65 years
• Body mass index (BMI) 30 - 50 kg/m2
• Receives care at one of the participating primary care clinics
• Resides in one location at least 5 days each week
• Possesses a smartphone with data plan
• Wi-Fi or Bluetooth internet connection in home

Exclusion Criteria:

• Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
• Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
• Likely to relocate and no longer be seen at UAB primary care in the next 2 years
• Weight loss ≥5% of body weight in past 6 months (other than postpartum)
• Weight >180 kg (396lbs) due to the limitation of the scale being used.
• Current participation in another weight loss study
• Bariatric surgery or revision in the past two years
• Prescription weight loss medications within the past 6 months
• Another household member already participating in the study
• Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants randomly assigned to this arm will receive standardized weight management educational materials plus a monetary gift of $60 that can be used to purchase health-promoting supplies to support weight management.	Behavioral: Standard Care; Standard care includes standardized educational materials to promote self-management of body weight along with provision of $60 for participants to purchase supplies or equipment to facilitate weight management.
Experimental: Daily Self-Weighing; Participants randomly assigned to this arm will receive standardized weight management educational materials plus a commercially available wireless scale. Participants will be instructed to weigh daily and view their weight on the scale's digital display.	Behavioral: Daily Self-Weighing; Participants will receive a wireless digital scale and will be asked to keep the scale in their home, weigh daily at the same time, and view their weight trajectory on the scale's digital display.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight from baseline to month 6	Body weight measured to the nearest 0.1 kg using a calibrated electronic scale	6 months
Change in body weight from baseline to month 12	Body weight measured to the nearest 0.1 kg using a calibrated electronic scale	12 months
Change in body weight from baseline to month 18	Body weight measured to the nearest 0.1 kg using a calibrated electronic scale	18 months
Change in body weight from baseline to month 24	Body weight measured to the nearest 0.1 kg using a calibrated electronic scale	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6	A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.	baseline to month 6
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12	A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.	month 6 to month 12
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18	A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.	month 12 to month 18
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24	A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.	month 18 to month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12	Self-efficacy (i.e., confidence in one's ability to execute the behaviors required to meet a goal) for healthy eating, physical activity, and weight loss will be assessed with the 12-item Self-Efficacy for Weight Loss Trials Scale	month 12
Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24	Self-efficacy (i.e., confidence in one's ability to execute the behaviors required to meet a goal) for healthy eating, physical activity, and weight loss will be assessed with the 12-item Self-Efficacy for Weight Loss Trials Scale	month 24
Mean score on the Eating Disorder Diagnostic Screening form at month 12	The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders	month 12
Mean score on the Eating Disorder Diagnostic Screening form at month 24	The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders	month 24
Mean score on the Body Shape Questionnaire-16A at month 12	The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance	month 12
Mean score on the Body Shape Questionnaire-16A at month 24	The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance	month 24
Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 12	The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms	month 12
Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 24	The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms	month 24
Healthcare utilization at month 12 assessed by the EuroQOL (EQ-5D-5L)	Self-reported use of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and associated costs will be collected using the EuroQOL (EQ-5D-5L)	baseline to month 12
Healthcare utilization at month 24 assessed by the EuroQOL (EQ-5D-5L)	Self-reported use of health care services (hospitalizations, ER/physician office visits, prescription drugs, etc.) and associated costs will be collected using the EuroQOL (EQ-5D-5L)	month 12 to month 24

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Indiana University; Cornell University

Publications and helpful links

General Publications

• Dutton GR, Kinsey AW, Howell CR, Pisu M, Dobelstein AE, Allison DB, Xun P, Levitsky DA, Fontaine K. The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology. Contemp Clin Trials. 2021 Aug;107:106463. doi: 10.1016/j.cct.2021.106463. Epub 2021 May 31.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: weight management; body weight; behavioral; weighing
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Overweight; Body Weight
• Other Study ID Numbers: R01DK118939 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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