Clinical trial NCT04044794: Daily Self-Weighing for Obesity Management in Primary Care
Official title: Daily Self-Weighing for Obesity Management in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: weight management
body weight
behavioral
weighing
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Cornell University
First posted: 2019-08-05
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in body weight from baseline to month 6
timeFrame: 6 months
measure: Change in body weight from baseline to month 12
timeFrame: 12 months
measure: Change in body weight from baseline to month 18
timeFrame: 18 months
measure: Change in body weight from baseline to month 24
timeFrame: 24 months
Secondary outcomes:
measure: Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6
timeFrame: baseline to month 6
measure: Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12
timeFrame: month 6 to month 12
measure: Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18
timeFrame: month 12 to month 18
measure: Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24
timeFrame: month 18 to month 24
Other outcomes:
measure: Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 12
timeFrame: month 12
measure: Mean self-efficacy score assessed by the Self-Efficacy for Weight Loss Trials Scale at month 24
timeFrame: month 24
measure: Mean score on the Eating Disorder Diagnostic Screening form at month 12
timeFrame: month 12
measure: Mean score on the Eating Disorder Diagnostic Screening form at month 24
timeFrame: month 24
measure: Mean score on the Body Shape Questionnaire-16A at month 12
timeFrame: month 12
measure: Mean score on the Body Shape Questionnaire-16A at month 24
timeFrame: month 24
measure: Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 12
timeFrame: month 12
measure: Mean score on the Patient Health Questionnaire-8 (PHQ-8) at month 24
timeFrame: month 24
measure: Healthcare utilization at month 12 assessed by the EuroQOL (EQ-5D-5L)
timeFrame: baseline to month 12
measure: Healthcare utilization at month 24 assessed by the EuroQOL (EQ-5D-5L)
timeFrame: month 12 to month 24
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
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.