Innovative Approaches to Diet, Exercise and Activity

Phase 2

Completed

Interventions: Behavioral: Standard Behavioral Weight Loss Intervention
Behavioral: Enhanced Weight Loss Intervention

Brief Summary: The prevalence of obesity in young adults has been increasing, and excessive body weight have been linked to numerous chronic conditions including cardiovascular disease, diabetes, many forms of cancer, and numerous musculoskeletal problems. This study will focus of the development and evaluation of interventions that may be appropriate for young adults (age 18-35 years) to improve weight loss outcomes following a 24 month intervention. The primary aim of this study is to examine whether an enhanced weight loss intervention (EWLI) that includes technology components results in improved weight loss in young adults (18-35 years of age) compared to a standard behavioral weight loss intervention (SBWP) over a period of 24 months. Eligible participants will also be assessed for body composition, body fat distribution, fitness, physical activity, dietary intake, and behavioral/psychosocial measures that may be predictive of behavior change. Assessments will occur at 0, 6, 12, 18, and 24 months. Subjects will participate in a 24 month behavioral weight loss program that includes a reduction in energy intake and moderate-to-vigorous intensity exercise (progressively increasing from 100 to 300 minutes per week). The technologies added to EWLI are text messaging, a wearable device that provides feedback on physical activity, and access to a website to monitor dietary behaviors.

Recruitment & Eligibility

Inclusion Criteria

18-35 years of age
Intending to be available for a 24 month intervention
An active cellular telephone that is capable of receiving text messaging
A computer and internet connectivity that can be used for the BodyMedia Fit system
Body mass index (BMI) between 25.0-39.9 kg/m2
The ability to provide medical clearance to participate in this study from their primary care physician
The ability to complete the baseline graded exercise test, and clearance from the study physician to participate in this study after reviewing the results from this study

Exclusion Criteria

Unable to provide informed consent
Household member on study staff
Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/PA/weight loss intervention study
Report regular use of systemic steroids, prescription weight loss drugs. "Regular use" is defined as "taking this medication most days of the week for the previous month"
Current treatment for eating disorder
Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
Current treatment for malignancy (other than non-melanoma skin cancer)
Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months
Investigator discretion
Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
Report losing >5% of current body weight in the previous 6 months
Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
Report taking medication that could affect metabolism or change body weight
Current treatment for diabetes mellitus

Arm && Interventions

Group	Intervention	Description
Standard Behavioral Weight Loss Intervention	Standard Behavioral Weight Loss Intervention	-
Enhanced Weight Loss Intervention	Enhanced Weight Loss Intervention	-

Primary Outcome Measures

Name	Time	Method
weight change	Change from baseline to 24 months	Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.

Secondary Outcome Measures

Name	Time	Method
cardiorespiratory fitness	0, 6, 12, 18, 24 months	A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.
dietary intake	0, 6, 12, 18, 24 months	A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
physical activity energy expenditure	0, 6, 12, 18, 24 months	A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
body composition	0, 6, 12, 18 24 months	Body composition will be assessed using DXA. This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.
psychosocial and behavioral measures	0, 6, 12, 18, 24 months	Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, sleep patterns, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).

Locations (1): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States