Psychological Support Strategies for Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Randomized Controlled Trial
Clinical Sciences
Clinical Trials and Supportive Activities
text messages
610
Clinical sciences
Diseases of the endocrine glands. Clinical endocrinology
Clinical Research
very low–carbohydrate diet
616
Behavioral and Social Science
T2D
Obesity
Metabolic and endocrine
Nutrition
Original Paper
Nutrition and Dietetics
Biomedical and Clinical Sciences
Prevention
Diabetes
self-monitoring
16. Peace & justice
RC648-665
3. Good health
Good Health and Well Being
glycemic control
eHealth
type 2 diabetes
weight loss
DOI:
10.2196/44295
Publication Date:
2023-05-11T13:45:35Z
AUTHORS (14)
ABSTRACT
Background
A very low–carbohydrate (VLC) nutritional strategy may improve glycemic control and weight loss in adults with type 2 diabetes (T2D). However, the supplementary behavioral strategies that might be able to improve outcomes using this nutritional strategy are uncertain.
Objective
This study aims to compare the impact of adding 3 different supplementary behavioral strategies to a web-based VLC diet intervention. To our knowledge, this is the first trial to randomize participants to different frequencies of dietary self-monitoring.
Methods
The study included 112 overweight adults with T2D (hemoglobin A1c ≥6.5%) taking no antiglycemic medications or only metformin. They received a remotely delivered 12-month VLC diet intervention. Participants were randomly assigned through a full factorial 2×2×2 design to supplementary strategies: either daily or monthly dietary self-monitoring, either mindful eating training or not, and either positive affect skills training or not. Our research goal was to determine whether 3 different supplemental strategies had at least a medium effect size (Cohen d=0.5).
Results
Overall, the VLC intervention led to statistically significant improvements in glycemic control (−0.70%, 95% CI −1.04% to −0.35%; P<.001), weight loss (−6.82%, 95% CI −8.57% to −5.08%; P<.001), and depressive symptom severity (Cohen d −0.67, 95% CI −0.92 to −0.41; P<.001). Furthermore, 30% (25/83) of the participants taking metformin at baseline reduced or discontinued their metformin. Only 1 Cohen d point estimate reached 0.5; daily (vs monthly) dietary self-monitoring had a worse impact on depressive symptoms severity (Cohen d=0.47, 95% CI −0.02 to 0.95; P=.06). None of the strategies had a statistically significant effect on outcomes. For changes in our primary outcome, hemoglobin A1c, the daily (vs monthly) dietary self-monitoring impact was 0.42% (95% CI −0.28% to 1.12%); for mindful eating, it was −0.47% (95% CI −1.15% to 0.22%); and for positive affect, it was 0.12% (95% CI −0.57% to 0.82%). Other results for daily (vs monthly) dietary self-monitoring were mixed, suggesting an increase in weight (0.98%) and depressive symptoms (Cohen d=0.47), less intervention satisfaction (Cohen d=−0.20), more sessions viewed (3.02), and greater dietary adherence (Cohen d=0.24). For mindful eating, the results suggested a benefit for dietary adherence (Cohen d=0.24) and intervention satisfaction (Cohen d=0.30). For positive affect, the results suggested a benefit for depressive symptoms (Cohen d=−0.32), the number of sessions viewed (3.68), dietary adherence (Cohen d=0.16), and intervention satisfaction (Cohen d=0.25).
Conclusions
Overall, our results support the use of a VLC diet intervention in adults with T2D. The addition of monthly (not daily) dietary self-monitoring, mindful eating, and positive affect skills training did not show a definitive benefit, but it is worth further testing.
Trial Registration
ClinicalTrials.gov NCT03037528; https://clinicaltrials.gov/ct2/show/NCT03037528
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