Shamizadeh Tahereh, Jahangiry Leila, Sarbakhsh Parvin, Ponnet Koen
Health Education and Health Promotion Department, School of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.
Tabriz Health Services Management Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Trials. 2019 Feb 4;20(1):98. doi: 10.1186/s13063-019-3220-z.
The present randomized controlled trial (RCT) evaluated the effectiveness of a theory-based physical activity (PA) intervention for rural patients with prediabetes. It was hypothesized that a PA intervention program based on the social cognitive theory (SCT) will modify fasting blood sugar (FBS) among rural people with prediabetes, which in turn will result in a decrease in diabetes incidence in the rural area.
A cluster RCT on prediabetic people was conducted in Ahar, East Azerbaijan Province, Iran. A PA intervention in prediabetes was performed over 16 weeks of follow-ups in 12 villages (six per arm). Residents (n = 272; n = 136 per arm) were invited to participate in the study through rural health care centers during screening for eligibility. Participants in the intervention and control groups were informed of their prediabetic conditions and encouraged to make appropriate changes to their lifestyles to modify their prediabetes. The intervention was an educational program delivered over 16 weeks and involved behavioral change techniques. Through the education program, the intervention group received one session per week lasting about 90 min (a total of 16 sessions). The importance of risk control with PA, the duration of hill climbing, as well as exercise and safety tips were explained in a brochure that was given to the participants. Anthropometric measures, glycemic status, and PA were evaluated at the beginning of the program and after 16 weeks of follow-up.
The PA program showed a reduction in FBS mg/dl at 16 weeks (large-effect-size Cohen's d = -0.63, p = 0.001) compared to the control condition. PA intervention led to a large effect size on diastolic blood pressure (BP, - 1.01) and a medium effect size for systolic BP (- 0.57), body mass index (BMI, - 0.33), and weight (- 0.35). Based on generalized linear mixed model analysis, significant reductions in FBS (mg/dl), BMI, weight, and diastolic BP were found in the intervention group compared to the control group.
Our results support the effectiveness of an SCT-based PA intervention to reduce the risk of prediabetes developing into diabetes among rural patients with prediabetes. Findings suggest that implementation of SCT-based PA intervention for a rural population at risk of diabetes has potential benefits.
Iranian Registry of Clinical Trials, IRCT201607198132N4 . Registered on 1 September 2017. Prospectively registered.
本随机对照试验（RCT）评估了基于理论的体育活动（PA）干预对农村糖尿病前期患者的有效性。研究假设基于社会认知理论（SCT）的PA干预项目将改善农村糖尿病前期人群的空腹血糖（FBS），进而降低农村地区糖尿病的发病率。
在伊朗东阿塞拜疆省的阿哈尔对糖尿病前期患者进行了一项整群RCT。在12个村庄（每组6个）进行了为期16周随访的糖尿病前期PA干预。在筛查 eligibility 期间，通过农村医疗保健中心邀请居民（n = 272；每组n = 136）参与研究。干预组和对照组的参与者被告知他们的糖尿病前期状况，并被鼓励对其生活方式做出适当改变以改善糖尿病前期状况。干预是一个为期16周的教育项目，涉及行为改变技术。通过该教育项目，干预组每周接受一次约90分钟的课程（共16次）。在分发给参与者的一本小册子中解释了通过PA控制风险的重要性、爬山的持续时间以及运动和安全提示。在项目开始时和随访16周后评估人体测量指标、血糖状态和PA。
与对照条件相比，PA项目在16周时显示FBS mg/dl降低（大效应量Cohen's d = -0.63，p = 0.001）。PA干预对舒张压（BP，-1.01）产生大效应量，对收缩压（-0.57）、体重指数（BMI，-0.33）和体重（-0.35）产生中等效应量。基于广义线性混合模型分析，与对照组相比，干预组的FBS（mg/dl）、BMI、体重和舒张压显著降低。
我们的结果支持基于SCT的PA干预在降低农村糖尿病前期患者糖尿病前期发展为糖尿病风险方面的有效性。研究结果表明，对有糖尿病风险的农村人群实施基于SCT的PA干预具有潜在益处。
伊朗临床试验注册中心，IRCT201607198132N4。于2017年9月1日注册。前瞻性注册。
