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Innovative Approaches to Diet, Exercise and Activity (IDEA)

Primary Purpose

Body Weight

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard Behavioral Weight Loss Intervention
Enhanced Weight Loss Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight focused on measuring obesity, overweight

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Behavioral Weight Loss Intervention

Enhanced Weight Loss Intervention

Arm Description

Outcomes

Primary Outcome Measures

weight change
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
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
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
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
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
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.).

Full Information

First Posted
May 24, 2010
Last Updated
August 4, 2015
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01131871
Brief Title
Innovative Approaches to Diet, Exercise and Activity
Acronym
IDEA
Official Title
Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
obesity, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Weight Loss Intervention
Arm Type
Active Comparator
Arm Title
Enhanced Weight Loss Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Weight Loss Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight change
Description
Body weight will be assessed on a digital scale to assess change in body weight over the 24 month intervention period.
Time Frame
Change from baseline to 24 months
Secondary Outcome Measure Information:
Title
body composition
Description
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.
Time Frame
0, 6, 12, 18 24 months
Title
cardiorespiratory fitness
Description
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.
Time Frame
0, 6, 12, 18, 24 months
Title
physical activity energy expenditure
Description
A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
Time Frame
0, 6, 12, 18, 24 months
Title
dietary intake
Description
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame
0, 6, 12, 18, 24 months
Title
psychosocial and behavioral measures
Description
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.).
Time Frame
0, 6, 12, 18, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Jakicic, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27654602
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. Erratum In: JAMA. 2016 Oct 11;316(14 ):1498.
Results Reference
derived
PubMed Identifier
26538477
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.
Results Reference
derived
PubMed Identifier
25599334
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.
Results Reference
derived

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Innovative Approaches to Diet, Exercise and Activity

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