Clinical trial NCT01131871: Innovative Approaches to Diet, Exercise and Activity
Official title: Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Body Weight
Keywords: obesity
overweight
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: weight change
timeFrame: Change from baseline to 24 months
Secondary outcomes:
measure: body composition
timeFrame: 0, 6, 12, 18 24 months
measure: cardiorespiratory fitness
timeFrame: 0, 6, 12, 18, 24 months
measure: physical activity energy expenditure
timeFrame: 0, 6, 12, 18, 24 months
measure: dietary intake
timeFrame: 0, 6, 12, 18, 24 months
measure: psychosocial and behavioral measures
timeFrame: 0, 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jakicic JM, Davis KK, Rogers RJ, King WC, Marcus MD, Helsel D, Rickman AD, Wahed AS, Belle SH. Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1161-1171. doi: 10.1001/jama.2016.12858.
citation: Jakicic JM, King WC, Marcus MD, Davis KK, Helsel D, Rickman AD, Gibbs BB, Rogers RJ, Wahed A, Belle SH. Short-term weight loss with diet and physical activity in young adults: The IDEA study. Obesity (Silver Spring). 2015 Dec;23(12):2385-97. doi: 10.1002/oby.21241. Epub 2015 Nov 5.
citation: Jakicic JM, King WC, Gibbs BB, Rogers RJ, Rickman AD, Davis KK, Wahed A, Belle SH. Objective Versus Self-Reported Physical Activity in Overweight and Obese Young Adults. J Phys Act Health. 2015 Oct;12(10):1394-400. doi: 10.1123/jpah.2014-0277. Epub 2015 Jan 19.