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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Daily Self-Weighing
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring weight management, body weight, behavioral, weighing

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Daily Self-Weighing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in body weight from baseline to month 6
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 12
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 18
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 24
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 2, 2019
Last Updated
March 8, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Indiana University, Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04044794
Brief Title
Daily Self-Weighing for Obesity Management in Primary Care
Acronym
SWOP
Official Title
Daily Self-Weighing for Obesity Management in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Indiana University, Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
weight management, body weight, behavioral, weighing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Daily Self-Weighing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Self-Weighing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight from baseline to month 6
Description
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Time Frame
6 months
Title
Change in body weight from baseline to month 12
Description
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Time Frame
12 months
Title
Change in body weight from baseline to month 18
Description
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Time Frame
18 months
Title
Change in body weight from baseline to month 24
Description
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6
Description
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.
Time Frame
baseline to month 6
Title
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12
Description
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.
Time Frame
month 6 to month 12
Title
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18
Description
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.
Time Frame
month 12 to month 18
Title
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24
Description
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.
Time Frame
month 18 to month 24
Other Pre-specified Outcome Measures:
Title
Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12
Description
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
Time Frame
month 12
Title
Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24
Description
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
Time Frame
month 24
Title
Mean score on the Eating Disorder Diagnostic Screening form at month 12
Description
The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders
Time Frame
month 12
Title
Mean score on the Eating Disorder Diagnostic Screening form at month 24
Description
The 22-item Eating Disorder Diagnostic Screening will monitor symptoms of eating disorders
Time Frame
month 24
Title
Mean score on the Body Shape Questionnaire-16A at month 12
Description
The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance
Time Frame
month 12
Title
Mean score on the Body Shape Questionnaire-16A at month 24
Description
The 16-item Body Shape Questionnaire-16A will monitor symptoms of body image disturbance
Time Frame
month 24
Title
Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 12
Description
The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms
Time Frame
month 12
Title
Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 24
Description
The Patient Health Questionnaire-8 (PHQ-8) will monitor depressive symptoms
Time Frame
month 24
Title
Healthcare utilization at month 12 assessed by the EuroQOL (EQ-5D-5L)
Description
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)
Time Frame
baseline to month 12
Title
Healthcare utilization at month 24 assessed by the EuroQOL (EQ-5D-5L)
Description
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)
Time Frame
month 12 to month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy E Dobelstein
Phone
2059751059
Email
adobelst@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gareth R Dutton, PhD
Phone
2059346876
Email
gdutton@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Dutton, PhD
Phone
205-934-6876
Email
gdutton@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34082075
Citation
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.
Results Reference
derived

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Daily Self-Weighing for Obesity Management in Primary Care

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