A Phase 2 interventional study of Standard weight loss intervention and Standard weight loss intervention plus technology in Obesity, sponsored by John M. Jakicic, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-08-05.
Sponsored by John M. Jakicic, PhD · Phase 2, Interventional, and Treatment
The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).
1,766 studies on the registry are indexed under Weight Loss; 278 are open to participants now.
This study's enrollment of 51 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →This is the only study on the registry with John M. Jakicic, PhD as lead sponsor.
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Exclusion Criteria:
Behavioral: Standard weight loss intervention
Behavioral: Standard weight loss intervention plus technology
Behavioral: Technology only
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
weight
Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.
Time frame: change from 0 to 6 months
cardiorespiratory fitness
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.
Time frame: 0, 6, 12, months
body composition
Body composition will be assessed using dual energy X-ray absorptiometry (DXA). This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.
Time frame: 0, 6, 12 months
physical activity
A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
Time frame: 0, 6, 12 months
dietary intake
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time frame: 0, 6, 12 months
psychosocial and behavioral measures
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, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).
Time frame: 0, 6, 12 months
Weight change
Body weight measured on a digital scale
Time frame: weight at 0, 6, and 12 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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