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Couple-Based Intervention for Diabetes

Trial question
What is the effect of couple-based intervention in patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 207
207 patients (102 female, 105 male).
Inclusion criteria: adult patients aged ≥ 55 years with T2DM living with spouses without diabetes.
Key exclusion criteria: previous participation in T2DM education courses; mental or physical dysfunction in spouses; diabetes in both the couples; no informed consent.
Interventions
N=106 couple-based intervention (4 weekly group education sessions and a telephone behavior change booster at 2 months targeting couple pairs).
N=101 individual-based care (4 weekly group education sessions and a telephone behavior change booster at 2 months targeting individual patients).
Primary outcome
Hemoglobin A1c levels in patients at 12 months
8.59%
8.67%
8.7 %
6.5 %
4.3 %
2.2 %
0.0 %
Couple-based intervention
Individual-based care
No significant difference ↔
No significant difference in HbA1c levels in patients at 12 months (8.59% vs. 8.67%; AD -0.08%, 95% CI -0.57 to 0.42).
Secondary outcomes
No significant difference in 36-Item Short Form Health Survey-Physical Component Summary score in spouses at 12 months (63.37 points vs. 61.73 points; AD 1.63 points, 95% CI -2.44 to 5.71).
No significant difference in Chinese version of the Diabetes Management Self-Efficacy Scale score in patients at 12 months (159.9 points vs. 162.3 points; AD -2.4 points, 95% CI -14.3 to 9.5).
No significant difference in physical activity, Metabolic Equivalent Task in patients at 12 months (3567.8 min/week vs. 3866.1 min/week; AD -298.3 min/week, 95% CI -1015.9 to 419.3).
Conclusion
In adult patients aged ≥ 55 years with T2DM living with spouses without diabetes, couple-based intervention was not superior to individual-based care with respect to HbA1c levels in patients at 12 months.
Reference
Conghui Yang, Jingyi Zhi, Yingxin Xu et al. A Couple-Based Intervention for Chinese Older Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452168.
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