Effect of a Stepped-Care Intervention Approach on Weight Loss in Adults: A Randomized Clinical Trial
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CONTEXT: Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches. OBJECTIVE: To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33% nonwhite, and 83% female) who were randomized to SBWI (n = 165) or STEP (n = 198) at 2 universities affiliated with academic medical centers in the United States (Step-Up Study). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. INTERVENTIONS: All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals. MAIN OUTCOME MEASURE: Mean change in weight over 18 months. Additional outcomes included resting heart rate and blood pressure, waist circumference, body composition, fitness, physical activity, dietary intake, and cost of the program. RESULTS: Of the 363 participants randomized, 260 (71.6%) provided a measure of mean change in weight over 18 months. The 18-month intervention resulted in weight decreasing from 93.1 kg (95% CI, 91.0 to 95.2 kg) to 85.6 kg (95% CI, 83.4 to 87.7 kg) (P < .001) in the SBWI group and from 92.7 kg (95% CI, 90.8 to 94.6 kg) to 86.4 kg (95% CI, 84.5 to 88.4 kg) in the STEP group (P < .001). The percentage change in weight from baseline to 18 months was -8.1% (95% CI, -9.4% to -6.9%) in the SBWI group (P < .001) compared with -6.9% (95% CI, -8.0% to -5.8%) in the STEP group (P < .001). Although the between-group difference in 18-month weight loss was not statistically different (-1.3 kg [95% CI, -2.8 to 0.2 kg]; P = .09), there was a significant group × time interaction effect (P = .03). The cost per participant was $1357 (95% CI, $1272 to $1442) for the SBWI group vs $785 (95% CI, $739 to $830) for the STEP group (P < .001). Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness. CONCLUSIONS: Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. Compared with SBWI, STEP resulted in clinically meaningful weight loss that cost less to implement. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00714168.
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The Jakicic study's purpose was evaluation of the adaptive intervention, not its construction.
“The aim of this study was not to construct an adaptive intervention; rather, the aim was to evaluate the above-described intervention.”
From Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research (2014) · cites this paper as [44]
Before the Jakicic study, the team chose the number and timing of decision stages, the single tailoring variable (weight loss), the treatment options, and the rules connecting weight loss to treatments at each step.
“In developing this AI prior to study, decisions were made (i) about the total number of decision stages, including when and how often they would occur (i.e., there was a step every 3 months over 18 months), (ii) to use one tailoring variable (i.e., weight loss), (iii) about the treatment options (i.e., group sessions, behavioral lessons, 1 vs 2 sessions of telephone counseling, individual sessions”
From Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research (2014) · cites this paper as [44]
Once those choices were made, the investigators compared the adaptive intervention with a standard behavioral weight-loss intervention in a two-arm RCT.
“After these decisions were made, the investigators evaluated this adaptive intervention versus a standard behavioral weight loss intervention using a 2-arm RCT.”
From Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research (2014) · cites this paper as [44]
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- Authors
- Jakicic, J. M., Tate, D. F., Lang, W., Davis, K. K., Polzien, K., Rickman, A. D., Erickson, K., Neiberg, R. H., & Finkelstein, E. A.
- Affiliations
- University of Pittsburgh (US)
- University of North Carolina at Chapel Hill (US)
- Wake Forest University Health Sciences (US)
- National University of Singapore (SG)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2012-06-27
- Volume
- 307
- Issue
- 24
- Pages
- 2617-26
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC4132634
- OpenAlex
- W2049460685
- Cited by
- 158
- References
- 28
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 7 · 2023: 1 · 2022: 8 · 2021: 7 · 2020: 10 · 2019: 23 · 2018: 12 · 2017: 18 · 2016: 12 · 2015: 16 · 2014: 22 · 2013: 12 · 2012: 3
- FWCI
- 16.35
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- National University of Singapore (submittedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL084400, HL084400)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Health Sciences › Health Professions › Pharmacy › Obesity and Health Practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- stepped-care intervention, weight loss, obesity, behavioral weight loss, hypocaloric diet, physical activity, group counseling, personalized treatment, cost-effectiveness, resting heart rate, blood pressure, waist circumference, body composition, adults with obesity, overweight adults, program costs, physical activity adherence, dietary intake, fitness, step-up
- MeSH terms
- Adolescent, Adult, Blood Pressure, Body Composition, Counseling, Diet, Reducing, Female, Heart Rate, Humans, Male, Middle Aged, Obesity, Physical Fitness, Weight Loss, Exercise, Body Mass Index, Treatment Outcome, Cost Savings, Overweight, Young Adult
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