Daily Self-Weighing for Obesity Management in Primary Care

NCT04044794 | Completed

• 1 other identifier: R01DK118939
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

weight management; body weight; behavioral; weighing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6

  baseline to month 6

• Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12

  month 6 to month 12

• Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18

  month 12 to month 18

• Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24

  month 18 to month 24

Other Outcomes (10)

• Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12

  month 12

• Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24

  month 24

• Mean score on the Eating Disorder Diagnostic Screening form at month 12

  month 12

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Daily Self-Weighing

EXPERIMENTAL

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

Interventions

Daily Self-Weighing BEHAVIORAL

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.

Daily Self-Weighing

Standard Care BEHAVIORAL

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.

Standard Care

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Indiana University: collaborator
• Cornell University: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Related Publications (1)

• 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.

  PMID: 34082075 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Body Weight; Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: November 4, 2020
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)