Combining Motivational Support, Meal Preparation Training, and a Tapering Course of Meal Replacements To Achieve Vascular Risk Reduction in Women With a Gestational Diabetes History (MoMM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- percentage change in weight in participant
研究概览
简要总结
Women with a history of 'diabetes in pregnancy' or Gestational Diabetes (GDM) have a high risk for type 2 diabetes later in life. This can often be prevented, however, with improvements in eating habits and higher physical activity levels. However, many women find it difficult to alter their lifestyle habits, especially if they have young children. In adults with type 2 diabetes, the investigators have been studying the effects of combining nutrition education with meal preparation training and pedometer-based self-monitoring to improve eating habits and increase activity levels. The investigators have shown that such a strategy can reduce hemoglobin A1C by 0.3% and correlates with small reductions in weight (Dasgupta et al, International Journal of Behavioural Nutrition and Physical Activity, 2012). In developing the present interventional study, we presented this strategy to women with a GDM history and asked them how they would modify it to suit their needs. They expressed strong interest in such an approach but emphasized a need to involve their spouses and provide childcare support. They did not express interest in use of meal replacements. Therefore, in MoMM-intervention phase, the investigators will examine the effects of a once per month (4 session) program combined with Internet/telephone-based support. The four sessions with include meal preparation training, strategies to limit mindless eating and improve meal content and portion control. All sessions will offer child care. Two sessions will involve spouses. The investigators will assess effects on weight, BMI, DXA measures of fat, and measures of insulin resistance and blood pressure. This single-arm intervention study may lead ultimately to a randomized controlled trial.
详细描述
The investigators have adopted a single-arm intervention pilot study to assess the potential effects of a nutrition/physical activity behavioural intervention in women with a history of GDM within the past 5 years. The investigators have designed the intervention to include in-person sessions- but at a feasible frequency for busy mothers- as well as telephone calls and an on-line discussion forum, to provide an ongoing source of support, information, and accountability. Further, participants' partners will be invited to some of the in-person sessions and childcare will be provided on-site. Importantly, there are no meal replacements included, despite the study title, because focus group discussions indicated that this was not of interest to the target population.
The investigators will hold in-person sessions at a frequency of once per month over a 4-month period. In addition to the in-person, on-site sessions, we will arrange for participants to have in a grocery store 'tour' led by a student from the McGill School of Dietetics and Human Nutrition BSc program. This will allow a review of label reading and interpretation as well as tips on produce selection. Details of the intervention are provided under the trial arm section below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prior history of GDM
- •Body mass index (BMI) ≥ 24 kg/m2
- •Ability to speak and read English or French
排除标准
- •Type 1 diabetes
- •Type 2 diabetes
- •Use of antihyperglycemic medication
- •Pregnant or planning to become pregnant again in the next year
- •Food allergies
- •Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
- •Current smoker
结局指标
主要结局
percentage change in weight in participant
时间窗: 16 to 20 weeks
Women with a GDM history within the past 5 years are enrolled with a BMI at or above 24 kg/m2. Weight will be measured to the nearest 0.1 kilogram with an automated scale. We will subtract the post intervention weight from the baseline weight to compute the change in weight. We will divide this value by the baseline weight to compute the percentage change in weight from baseline.
次要结局
- change in BMI(16 to 20 weeks)
- change in diastolic blood pressure(16 to 20 weeks)
- change in total cholesterol(16 to 20 weeks)
- Change in eating outside of the home(16 to 20 weeks)
- Change in anxiety and depression(16-20 weeks)
- change in total body fat(16 to 20 weeks)
- adbominal adiposity(16 to 20 weeks)
- change in fasting insulin levels(16 to 20 weeks)
- change in 2-hour insulin level following 75-gram glucose load(16 to 20 weeks)
- change in daily step count(16 to 20 weeks)
- change in high density lipoprotein cholesterol(16 to 20 weeks)
- change in waist to hip ratio(16 to 20 weeks)
- change in fasting glucose levels(16 to 20 weeks)
- change in 1-hour glucose level following 75-gram glucose load(16 to 20 weeks)
- change in 1-hour insulin level following 75-gram glucose load(16 to 20 weeks)
- change in Homeostatic Model Assessment of insulin resistance (HOMA-IR)(16 to 20 weeks)
- change in low density lipoprotein cholesterol(16 to 20 weeks)
- Change in eating habits(16 to 20 weeks)
- Change in measure of self-efficacy for eating control(16-20 weeks)
- change in waist circumference(16 to 20 weeks)
- Proportion with elevated 1-hour glucose level following 75-gram glucose load(16 to 20 weeks)
- change in 2-hour glucose level following 75-gram glucose load(16 to 20 weeks)
- change in insulin sensitivity index 0, 120 (ISI)(16 to 20 weeks)
- change in physical activity level(16 to 20 weeks)
- change in total cholesterol to high density lipoprotein cholesterol ratio(16 to 20 weeks)
- change in systolic blood pressure(16 to 20 weeks)
- Change in triglyceride levels(16 to 20 weeks)
- change in weight of participant's spouse(16 to 20 weeks)
- Change in fiber intake(16 to 20 weeks)
- Change in reported physical activity(16 to 20 weeks)
- Change in cooking ability(16 to 20 weeks)
- Change in mindful eating(16 to 20 weeks)
- Change in perceived stress(16 to 20 weeks)
研究者
Kaberi Dasgupta, MD, MSc, FRCP (C)
Associate Professor, McGill University
McGill University Health Centre/Research Institute of the McGill University Health Centre