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Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

Phase 2
18 Years
35 Years
Open (Enrolling)
Body Weight

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Trial Information

Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

weight change

Outcome Description:

Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.

Outcome Time Frame:

Change from baseline to 24 months

Safety Issue:


Principal Investigator

John M Jakicic, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:

U01 HL096770



Start Date:

September 2010

Completion Date:

June 2014

Related Keywords:

  • Body Weight
  • obesity
  • overweight
  • Body Weight



University of PittsburghPittsburgh, Pennsylvania  15261