Clinical trial NCT01646086: Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care
Official title: Weight Tracking and Weight Loss Outcomes: Establishing the Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Weight Loss
Self-Weighing
Weight Tracking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-07-20
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking).

The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.

Detailed description: Given the pernicious reach of obesity and the evidence that current behavioral treatments are modestly effective at changing weight, efforts to refine behavioral recommendations in order to improve weight loss interventions are crucial. Frequency of tracking body weight presents itself as a prime target for behavioral enhancement during weight loss. Daily self-monitoring (e.g., of dietary intake and physical activity) is already well-established as a central component of the behavioral weight loss process. However, the current standard of care in behavioral weight loss with regard to weighing is weekly tracking of weight, and some programs caution against any weight tracking. It has been suggested that frequent weight tracking may have a negative impact on mental health and outcomes during weight loss, but there are minimal data that address this concern experimentally in the context of an active weight loss program. Observational evidence from behavioral weight control trials and community studies suggests that greater frequency of tracking weight is associated with better weight outcomes. Stronger experimental evidence is needed to establish a causal link between weight tracking and weight outcomes and to elucidate the impact on mental health during weight loss. To achieve the long-term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternate model of care with very limited data (no weight tracking). In pursuit of study goals, 336 overweight and obese adults will be recruited and randomized to one of three 12-month weight loss interventions with a 12-month follow-up (24 months total time in study): the standard of care (weekly weight tracking during weight loss), an enhanced condition (daily weight tracking during weight loss), or a comparison condition (no weight tracking during weight loss). The rationale behind this proposal is that within the context of social ecology and a social-cognitive framework of behavior change, enhancement of this key environmental feature (i.e., the weight tracking environment) during weight loss will contribute to success by promoting self-efficacy for this critical behavior. Specific aims of the study will seek to determine the effects of weight tracking frequency on the weight loss process and outcomes, as well as to elucidate the effects of weight tracking frequency on mental health during weight loss. This study will have the expected outcome of enhancing the standard of care for weight loss, leading to better weight control for overweight and obese adults and thus directly mitigating the public health impact of the obesity crisis.

Eligibility criteria: Inclusion Criteria:

* women and men
* 18-64 years of age
* BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
* interest in joining a weight loss program
* have a computer, email, and wifi connection at home
* live in the Minneapolis/Saint Paul, Minnesota area

Exclusion Criteria:

* weight in the underweight to low normal (BMI \< 22) or morbidly obese (BMI \> 35) ranges
* current eating disorder or history of eating disorders
* current major depression or psychotic disorder diagnosis
* current cardiovascular disease or diabetes diagnosis
* current participation in a weight loss program
* current pregnancy
* previous weight loss surgery

Primary outcomes:
measure: Change in Body Weight Over Time
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
Secondary outcomes:
measure: Demographic Measures
timeFrame: baseline
measure: Weight Tracking and Self-Monitoring Adherence
timeFrame: throughout intervention
measure: Perceptions of Weight Tracking
timeFrame: 6 months, 12 months, 18 months, and 24 months
measure: Barriers to Weight Tracking
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Self-Efficacy for Weight Loss Behaviors
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Routine Health Habits
timeFrame: baseline, 12 months, and 24 months
measure: Dietary Intake
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Physical Activity
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Body Image
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Self-Esteem
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Depression
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Anxiety
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Mood States
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
measure: Life Events
timeFrame: baseline, 12 months, and 24 months
measure: Eating Disorder Symptoms
timeFrame: baseline, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jennifer Linde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crane MM, Gavin K, Wolfson J, Linde JA. How Accurate are Recalls of Self-Weighing Frequency? Data from a 24-Month Randomized Trial. Obesity (Silver Spring). 2018 Aug;26(8):1296-1302. doi: 10.1002/oby.22239. Epub 2018 Aug 1.