Innovative Approaches to Diet, Exercise and Activity

NCT01131871 | Completed Phase 2 DMC

• 1 other identifier: U01HL096770
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight

Keywords

obesity; overweight

Outcome Measures

Primary Outcomes (1)

• weight change

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

  Change from baseline to 24 months

Secondary Outcomes (5)

• body composition

  0, 6, 12, 18 24 months

• cardiorespiratory fitness

  0, 6, 12, 18, 24 months

• physical activity energy expenditure

  0, 6, 12, 18, 24 months

• dietary intake

  0, 6, 12, 18, 24 months

• psychosocial and behavioral measures

  0, 6, 12, 18, 24 months

Study Arms (2)

Standard Behavioral Weight Loss Intervention

ACTIVE COMPARATOR

Behavioral: Standard Behavioral Weight Loss Intervention

Enhanced Weight Loss Intervention

EXPERIMENTAL

Behavioral: Enhanced Weight Loss Intervention

Interventions

Standard Behavioral Weight Loss Intervention BEHAVIORAL

Subjects in this group will receive our standard behavioral weight control program that is delivered in an in-person group-based format. At month 7 subjects will also be given access to a study website to monitor eating and activity behaviors, and to have electronic access to standardized intervention materials. At month 7 subjects will also receive targeted study-related text messages that otherwise would have been provided in paper format.

Standard Behavioral Weight Loss Intervention

Enhanced Weight Loss Intervention BEHAVIORAL

Subjects in this group will participate in a weight loss intervention that includes technology enhancements. These enhancements will include the addition of intervention specific targeted and tailored text messaging and the BodyMedia Fit System® beginning at Month 7. At month 7 subjects in EWLI will also receive the same targeted study-related text messages provided to SBWP that otherwise would have been provided in paper format.

Enhanced Weight Loss Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (3)

• 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.

  PMID: 27654602 DERIVED

• 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.

  PMID: 26538477 DERIVED

• 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.

  PMID: 25599334 DERIVED

MeSH Terms

Conditions

Body Weight; Obesity; Overweight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• John M Jakicic, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 27, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

US (1)