Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial
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Jie Liu1, Job G Godino2, Gregory J Norman2
1School of Medicine, University of California, San Diego, La Jolla, CA, United States of America.
Abstract:
Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC.
Trial Registration:
ClinicalTrials.gov, NCT01134029.
Insights
A stepped-down intervention for obesity and cardiovascular disease risk factors (CVDRFs) in primary care led to significantly greater weight loss compared to enhanced usual care over 20 months. This approach effectively reduced body weight and BMI in obese adults.
Area of Science:
- Cardiology
- Obesity Medicine
- Primary Care Research
Background:
- Concurrent obesity and cardiovascular disease risk factors (CVDRFs) present a significant challenge in primary care.
- Primary care-based interventions with stepped-down intensity, contingent on weight loss success, have not been extensively studied.
Purpose of the Study:
- To evaluate the efficacy of a "planned care for obesity and risk reduction" (PCORR) intervention using a stepped-down approach compared to enhanced usual care (EUC) for obese adults with CVDRFs.
Main Methods:
- A 20-month, single-blind randomized controlled trial involving 262 obese adults (aged 25-70) with at least one CVDRF across five primary care clinics.
- The PCORR group received multi-modal, stepped-down interventions (individual/group sessions via various channels), while the EUC group received less frequent individual sessions.
- Intervention intensity in PCORR decreased in three steps based on achieved weight loss.
Main Results:
- The PCORR group achieved a significantly greater mean body weight reduction of 6.1% compared to 2.8% in the EUC group (p=0.007).
- A significant treatment by time interaction (p=0.009) indicated greater BMI reduction in the PCORR group (35.2 to 33.7 kg/m²).
- At 20 months, 40.7% of PCORR patients were in step 1, 23.8% in step 2, and 15.4% in step 3, with 25.2% lost to follow-up.
Conclusions:
- The stepped-down PCORR intervention demonstrated superior effectiveness in promoting weight loss among obese adults with CVDRFs in a primary care setting over 20 months.
- This approach offers a promising strategy for managing obesity and associated cardiovascular risks within primary care.
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