Effects of a Community-Based Healthy Lifestyle Intervention Program (Co-HELP) among Adults with Prediabetes in a Developing Country: A Quasi-Experimental Study

Background
The prevalence of type 2 diabetes among Malaysian adults has increased by more than two folds over the past two decades. Strategies to collaborate with the existing community partners may become a promising channel for wide-scale dissemination of diabetes prevention in the country. The objectives of this study were to determine the effects of community-based lifestyle interventions delivered to adults with prediabetes and their health-related quality of life as compared to the usual care group.
Methods
This was a quasi-experimental study conducted in two sub-urban communities in Seremban, Malaysia. A total of 268 participants with prediabetes aged between 18 to 65 years old were assigned to either the community-based lifestyle intervention (Co-HELP) (n = 122) or the usual care (n = 146) groups. The Co-HELP program was delivered in partnership with the existing community volunteers to incorporate diet, physical activity, and behaviour modification strategies. Participants in the Co-HELP group received twelve group-based sessions and two individual counselling to reinforce behavioural change. Participants in the usual care group received standard health education from primary health providers in the clinic setting. Primary outcomes were fasting blood glucose, 2-hour plasma glucose, and HbA1C. Secondary outcomes included weight, BMI, waist circumference, total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, systolic and diastolic blood pressure, physical activity, diet, and health-related quality of life (HRQOL).
Results
An intention-to-treat analysis of between-groups at 12-month (mean difference, 95% CI) revealed that the Co-HELP participants’ mean fasting plasma glucose reduced by -0.40 mmol/l (-0.51 to -0.28, p<0.001), 2-hour post glucose by -0.58 mmol/l (-0.91 to -0.24, p<0.001), HbA1C by -0.24% (-0.34 to -0.15, p<0.001), diastolic blood pressure by -2.63 mmHg (-3.79 to -1.48, p<0.01), and waist circumference by -2.44 cm (-4.75 to -0.12, p<0.05) whereas HDL cholesterol increased by 0.12 mmol/l (0.05 to 0.13, p<0.01), compared to the usual care group. Significant improvements were also found in HRQOL for both physical component (PCS) by 6.51 points (5.21 to 7.80, p<0.001) and mental component (MCS) by 7.79 points (6.44 to 9.14, p<0.001). Greater proportion of participants from the Co-HELP group met the clinical recommended target of 5% or more weight loss from the initial weight (24.6% vs 3.4%, p<0.001) and physical activity of >600 METS/min/wk (60.7% vs 32.2%, p<0.001) compared to the usual care group.
Conclusions
This study provides evidence that a culturally adapted diabetes prevention program can be implemented in the community setting, with reduction of several diabetes risk factors and improvement of HRQOL. Collaboration with existing community partners demonstrated a promising channel for the wide-scale dissemination of diabetes prevention at the community level. Further studies are required to determine whether similar outcomes could be achieved in communities with different socioeconomic backgrounds and geographical areas.
Trial Registration
IRCT201104106163N1

背景：过去二十年间，马来西亚成年人中2型糖尿病的患病率增幅超过两倍。与现有社区伙伴开展合作的策略，或可成为该国大规模推广糖尿病预防工作的可行渠道。本研究旨在对比基于社区的生活方式干预对糖尿病前期成年人的干预效果，以及该干预对受试者健康相关生存质量（health-related quality of life, HRQOL）的影响，研究对照为常规护理组。
方法：本研究为类实验性研究，在马来西亚芙蓉市的两个城郊社区开展。共计纳入268名年龄介于18至65岁的糖尿病前期受试者，按分组分别接受基于社区的生活方式干预（Co-HELP，n=122）或常规护理（n=146）。Co-HELP项目联合现有社区志愿者开展，内容涵盖饮食、体力活动与行为矫正策略。干预组受试者共参与12次团体课程，并接受2次个体咨询以强化行为改变。常规护理组受试者则在诊所场景下接受初级医疗服务提供者提供的标准健康教育。本研究的主要结局指标为空腹血糖、2小时血浆葡萄糖及糖化血红蛋白（HbA1C）；次要结局指标包括体重、体质指数（BMI）、腰围、总胆固醇、甘油三酯、低密度脂蛋白（LDL）胆固醇、高密度脂蛋白（HDL）胆固醇、收缩压与舒张压、体力活动、饮食情况及健康相关生存质量（HRQOL）。
结果：对12个月随访时的组间意向性治疗分析（平均差值、95%置信区间）显示，与常规护理组相比，Co-HELP组受试者的空腹血浆葡萄糖平均降低0.40 mmol/L（-0.51~-0.28，p<0.001），餐后2小时血糖平均降低0.58 mmol/L（-0.91~-0.24，p<0.001），糖化血红蛋白平均降低0.24%（-0.34~-0.15，p<0.001），舒张压平均降低2.63 mmHg（-3.79~-1.48，p<0.01），腰围平均降低2.44 cm（-4.75~-0.12，p<0.05）；而高密度脂蛋白胆固醇平均升高0.12 mmol/L（0.05~0.13，p<0.01）。此外，两组的健康相关生存质量均出现显著改善：躯体组分（PCS）平均提升6.51分（5.21~7.80，p<0.001），心理组分（MCS）平均提升7.79分（6.44~9.14，p<0.001）。与常规护理组相比，Co-HELP组中达到临床推荐的体重较基线下降5%及以上的受试者比例更高（24.6% vs 3.4%，p<0.001），且每周体力活动量超过600代谢当量分钟的受试者比例也更高（60.7% vs 32.2%，p<0.001）。
结论：本研究证实，适配本土文化的糖尿病预防项目可在社区场景中落地，能够降低多项糖尿病风险因素并改善健康相关生存质量。与现有社区伙伴开展合作，证明是在社区层面大规模推广糖尿病预防工作的可行渠道。未来仍需开展进一步研究，以明确在不同社会经济背景与地理区域的社区中是否可取得类似效果。
试验注册：IRCT201104106163N1