Innovative Approaches to Diet, Exercise and Activity (IDEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John M. Jakicic, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01131871
First received: May 24, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Body Weight
Behavioral: Standard Behavioral Weight Loss Intervention
Behavioral: Enhanced Weight Loss Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • weight change [ Time Frame: Change from baseline to 24 months ] [ Designated as safety issue: No ]
    Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.


Secondary Outcome Measures:
  • body composition [ Time Frame: 0, 6, 12, 18 24 months ] [ Designated as safety issue: No ]
    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.

  • cardiorespiratory fitness [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    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.

  • physical activity energy expenditure [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.

  • dietary intake [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • psychosocial and behavioral measures [ Time Frame: 0, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    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.).


Estimated Enrollment: 480
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Behavioral Weight Loss Intervention Behavioral: Standard Behavioral Weight Loss Intervention
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.
Experimental: Enhanced Weight Loss Intervention Behavioral: Enhanced Weight Loss Intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131871

Contacts
Contact: John M Jakicic, Ph.D. 412-488-4184 jjakicic@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: John M Jakicic, PhD    412-488-4184    jjakicic@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John M Jakicic, Ph.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: John M. Jakicic, PhD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01131871     History of Changes
Other Study ID Numbers: U01 HL096770
Study First Received: May 24, 2010
Last Updated: June 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
obesity
overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014