Daily Self-Weighing for Obesity Management in Primary Care

Overweight and Obesity Clinical Trial

— SWOP  

Official title:

Daily Self-Weighing for Obesity Management in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04044794
• Other study ID #: R01DK118939
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 396
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Cornell University, Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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