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Innovative Approaches to Diet, Exercise and Activity (IDEA)

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ClinicalTrials.gov Identifier: NCT01131871
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
John M. Jakicic, PhD, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Body Weight Behavioral: Standard Behavioral Weight Loss Intervention Behavioral: Enhanced Weight Loss Intervention Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults
Study Start Date : September 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. weight change [ Time Frame: Change from baseline to 24 months ]
    Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.


Secondary Outcome Measures :
  1. body composition [ Time Frame: 0, 6, 12, 18 24 months ]
    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.

  2. cardiorespiratory fitness [ Time Frame: 0, 6, 12, 18, 24 months ]
    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.

  3. physical activity energy expenditure [ Time Frame: 0, 6, 12, 18, 24 months ]
    A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.

  4. dietary intake [ Time Frame: 0, 6, 12, 18, 24 months ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  5. psychosocial and behavioral measures [ Time Frame: 0, 6, 12, 18, 24 months ]
    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.).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131871


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: John M Jakicic, Ph.D. University of Pittsburgh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John M. Jakicic, PhD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01131871    
Other Study ID Numbers: U01HL096770 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by John M. Jakicic, PhD, University of Pittsburgh:
obesity
overweight
Additional relevant MeSH terms:
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Body Weight