Innovative Approaches for Diet, Exercise, and Activity (IDEA)
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Accession Number
HLB01781818a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
September 2010 – November 2014
NHLBI Division
DCVS
Dataset(s) Last Updated
July 2, 2018
Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT01131871
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/27654602
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
None
Objectives
To test the hypothesis that, compared with a standard behavioral weight loss intervention, a technology-enhanced intervention would result in greater weight loss.
Background
A significant portion of the United States population, including young adults, is overweight or obese. Being overweight can lead to a number of related health complications and therefore it is a significant public health concern. Behavioral interventions that emphasize diet and physical activity are effective for short term weight loss, however sustained weight loss is more difficult to achieve. Technologies such as wearable devices have become widely available and marketed as means to improve lifestyle by tracking physical activity and other health metrics. Research has demonstrated that such technologies, when paired with a behavioral intervention, can lead to modest weight loss in the short-term. However, additional research is needed regarding use of technologies for long-term behavior change. In addition, many weight loss studies have focused on middle-age or older adults so additional research is needed for younger cohorts. Therefore the Innovative Approaches to Diet, Exercise and Activity (IDEA) study sought to evaluate the benefit of technological interventions in sustained weight lost for young adults.
Participants
Eligible participants included adults 18 to 35 years of age with a body mass index within 25.0 to <40.0 kg/m2 that had access to a cellular telephone with text messaging and a computer with internet access. Participants were also required to have medical clearance from their primary care physician. Exclusion criteria included recent or planned pregnancy, breast feeding, hypertension, diabetes, participation in another weight loss program, and use of medications that could impact body weight, metabolism, heart rate, or blood pressure. 232 participants were randomized to the standard behavioral intervention and 237 participants were randomized to the enhanced behavioral intervention.
Design
IDEA was a randomized clinical trial conducted as part of the Early Adult Reduction of weight through LifestYle intervention (EARLY) Trials consortium. Eligible participants were stratified by sex and race, and randomized to either a standard behavioral weight loss intervention (SBWI) or an enhanced weight loss intervention (EWLI).
For the first six months, both groups received the same weight loss interventions. This included weekly group-based behavioral sessions intended to promote adherence to weight loss behaviors through feedback on weight change and educational materials. In addition, calorie intake goals were prescribed at baseline based on weight, and adjusted as needed according to rate of weight loss, with dietary fat limited to 20-30% of caloric intake. Sample meal plans were provided to participants. Furthermore, participants were asked to engage in non-supervised moderate-to-vigorous physical activity starting at 100 minutes a week and gradually increased to 300 minutes per week. Participants self-monitored diet and physical activity in a diary, which were provided weekly to study staff for feedback.
After six months, participants in the SBWI group additionally received weekly text messaging prompts, monthly phone calls, and access to a study website with educational materials and the ability to self-monitor diet and physical activity. Participants in the EWLI group also received these interventions in addition to using wearable technology that measured energy expenditure and physical activity. The technology included a web-based interface that allowed participants to receive feedback on recorded physical activity and self-report dietary intake, in place of the self-monitoring done by the SWBI group on the study website. The group behavioral sessions continued monthly for both intervention groups.
Measurements were performed at 0, 6, 12, 18, and 24 months, which included weight, body composition assessed via dual-energy x-ray absorptiometry from a total body scan, cardiorespiratory fitness assessed via a submaximal graded exercise test, and physical activity assessed via a portable device worn for one week. Diet from the previous month was assessing using an online Diet History Questionnaire and DietCalc software. Sex, race, ethnicity, education, income, employment status, smoking status, alcohol consumption, and depressive symptoms were self-reported using questionnaires. The primary outcome measure was change in weight from baseline to 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake.
Conclusions
Although both groups had significant improvements in body composition, fitness, physical activity, and diet, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months.
Jakicic JM, Davis KK, Rogers RJ, et al. Effect of Wearable Technology Combined with a Lifestyle Intervention on Long-Term Weight Loss: the IDEA Randomized Clinical Trial. JAMA. 2016;316(11):1161-1171. doi:10.1001/jama.2016.12858.
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Resources Available
Study Datasets OnlyStudy Documents
- Data Dictionary (PDF - 1.0 MB)
- Annotated Forms (PDF - 1.5 MB)
- Protocol (PDF - 460.1 KB)
- Publications (PDF - 286.2 KB)
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