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Body WeightPhase 2IDEANCT01131871

Innovative Approaches to Diet, Exercise and Activity

A Phase 2 study testing Standard Behavioral Weight Loss Intervention and Enhanced Weight Loss Intervention in people with Body Weight, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Body Weight
What is being tested?
Standard Behavioral Weight Loss Intervention and Enhanced Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
471 participants
Where
1 siteUnited States
Study dates
Sep 2010to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15203

Other trials in United States

About this study

Official title: Enhanced Behavioral Intervention to Improve Long-Term Weight Loss in Young Adults

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
Being tested
Standard Behavioral Weight Loss Intervention, Enhanced Weight Loss Intervention
Keywords
obesity, overweight
Medical subject headings
Body Weight, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Behavioral Weight Loss InterventionBehavioural

    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.

  • Enhanced Weight Loss InterventionBehavioural

    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.

Study groups in NCT01131871
Study groupRoleWhat they receive
Standard Behavioral Weight Loss InterventionActive comparatorNot described
Receives: Behavioral: Standard Behavioral Weight Loss Intervention
Enhanced Weight Loss InterventionExperimentalNot described
Receives: Behavioral: Enhanced Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight change

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

    Measured: Change from baseline to 24 months

Secondary outcomes (5)

  1. 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.

    Measured: 0, 6, 12, 18 24 months

  2. 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.

    Measured: 0, 6, 12, 18, 24 months

  3. 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.

    Measured: 0, 6, 12, 18, 24 months

  4. 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.

    Measured: 0, 6, 12, 18, 24 months

  5. 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.).

    Measured: 0, 6, 12, 18, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01131871
Sponsor's protocol ID
U01HL096770
Acronym
IDEA
Status last verified
Aug 2015
First submitted
24 May 2010
Last updated
5 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27654602

  • 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.

    PubMed 26538477

  • 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.

    PubMed 25599334

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard Behavioral Weight Loss Intervention and Enhanced Weight Loss Intervention in people with Body Weight, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight change (time frame: Change from baseline to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01131871, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015; AzTrials last refreshed its copy on 2 Nov 2026.

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