Predictors of Behavioral Obesity Treatment Outcomes
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable environments -- account for disparities in weight loss outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years old
Obesity (body mass index ≥30 kg/m2)
Meets criteria for either the lower SES or higher SES cohort
Disqualifiers
Not fluent in English
Change in income or financial assets exceeding ±75% of federal poverty guideline within the past 12 months, or expected in the next 6 months, if this change would result in reclassification on SES.
Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral weight loss treatment
BehavioralThe weight loss intervention consists of the first 6 months of the Centers for Disease Control and Prevention's Prevent T2 program.
Treatment groups
230 Participants
are divided into 1 treatment groupGroup A: Standard-of-care behavioral weight loss treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Weight change
Weight change, reported as a percentage of baseline weight
Time frame
Months 2, 4, and 6Secondary outcomes
1
Adherence to dietary self-monitoring
Adherence to daily dietary self-monitoring will be scored as a binary variable (adherent vs. non-adherent) based on whether a subject recorded ≥50% of prescribed daily calorie intake goal on a given day. For example, an individual with a goal of 1350 kcal/d would be considered adherent on days in which at least 675 kcal was recorded.
Time frame
Months 2, 4, and 62
Adherence to physical activity recommendations
Physical activity and sedentary time will be measured objectively through a 7-day accelerometry protocol using ActiGraph wGT3X-BT (Pensacola, FL) accelerometers. Physical activity intensity will be scored based on established cutpoints, and minutes of moderate-vigorous physical activity (counted in bouts of ≥10 mins) will be calculated on each day of the assessment period.
Time frame
Months 2, 4, and 63
Frequency of dietary lapses
The occurrence of dietary lapses will be measured using ecological momentary assessment. Based on prior work, lapses are defined as "eating or drinking likely to cause weight gain, and/or put weight loss/maintenance at risk." If a lapse is endorsed at a given ambulatory assessment, subjects will classify them into one of four non-exclusive subtypes: (1) eating large portions, (2) eating at unplanned times, (3) eating foods inconsistent with weight control, or (4) eating when not hungry.
Time frame
Months 2, 4, and 6Sponsors and contacts
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Source ClinicalTrials.gov