whole food plant-based
Effects of a hybrid online/in-person implementation of the complete health improvement program on biomarkers, biometrics, and drug utilization in type 2 diabetes mellitus: a pilot randomized-controlled trial
28 April 2026
Morland T, McNally R, VanEnkevort E, Wilk T, Persing J, Schulze A, Blessing K, Packer S, Kirchner HL.
Summary
What the study found
This pilot study examined how a structured lifestyle intervention called the Complete Health Improvement Program (CHIP) affects adults with Type 2 Diabetes who also have access to modern medications. While both the lifestyle group and the standard care group improved their blood sugar levels, only those in the lifestyle program managed to reduce their medication dependence and lose significant abdominal fat.
Key findings
- Participants in the lifestyle intervention group were able to wean off insulin therapy, while those in the control group required increased doses.
- The program led to a significant reduction in waist circumference, with participants losing over four inches on average compared to a slight increase in the control group.
- Individuals who completed the program reported subjective improvements in their nutrition, exercise, and sleep quality.
- Both the intervention and standard care groups achieved similar reductions in HbA1c levels, suggesting lifestyle changes can match the blood-sugar-lowering effects of modern pharmaceutical management.
Practical takeaways
For those managing metabolic health, participating in a comprehensive lifestyle medicine program can lead to significant improvements in body composition and a reduced reliance on intensive medications. Adopting a structured approach to diet and activity may provide health benefits that standard medical care alone cannot achieve, particularly regarding the reduction of dangerous visceral fat.
Limitations
The study was a pilot trial with a very small sample size of only 25 participants, which limits the ability to apply these results to the general population. There were also challenges with recruitment and retention, meaning more research is needed to see if these results hold up in larger, more diverse groups.
Abstract
<h4>Background</h4>Randomized-controlled trials of the Complete Health Improvement Program (CHIP) were conducted before new-generation pharmacotherapies, such as GLP-1 and SGLT2 agents, were available. Other attempts to characterize the impact of CHIP since the advent of modern therapies lacked control groups. A new study is needed to evaluate the impact of CHIP on a population with access to modern pharmacotherapies.<h4>Methods</h4>Patients with type 2 diabetes mellitus (T2DM) were enrolled. Patients were randomly assigned to CHIP over 12 weeks in a hybrid online/in-person format plus usual care or usual care alone, which consisted of access to standard Geisinger Health Plan diabetes-related services. Feasibility measures included recruitment, retention and participation rates. Clinical efficacy outcomes included change in HbA1c, weight, waist circumference, lifestyle survey results, and diabetes drug utilization by drug class at 3 and 6 months versus baseline.<h4>Results</h4>Recruitment fell short of the targeted 60 patients (N = 25 enrolled, 13 and 12 patients randomized to the intervention and control groups, respectively). 69% of intervention participants who attended baseline visits completed at least 50% of classes, which was slightly below the target of ≥ 70%. Lifestyle survey participation was low but suggested improvements in nutrition, exercise, and sleep among intervention participants who did complete surveys. At 6 months, change in HbA1c was - 0.46% [95% CI - 0.93, 0.01] and - 0.58% [95% CI - 0.95, - 0.22] for the intervention and control groups, respectively. Patients in the intervention group collectively weaned off insulin therapy vs. escalated insulin therapy in the control group. There was a reduction in waist circumference in the intervention group compared to an increase in the control group (- 4.65 [95% CI - 9.71, 0.41] vs. 0.56 [95% CI - 1.66, 2.78] inches, respectively).<h4>Conclusions</h4>Lifestyle and clinical data from this pilot clinical trial mostly aligned with previous studies. A larger trial is needed to confirm the benefits of CHIP for body composition, to further characterize the clinical effects of CHIP participation, and to understand interactions between lifestyle intervention and modern T2DM pharmacotherapy. Feasibility issues identified in this pilot study would need to be overcome to accomplish such a trial.<h4>Trial registration</h4>This study was registered with ClinicalTrials.gov on 05/20/2021.<h4>Registration number</h4>NCT04924400 .
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