A Recipe for Health: Evaluating the Effectiveness of a Diabetes Prevention Program on Dietary Behaviours and Diabetes Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- change in hemoglobin A1c% (HbA1c%)
研究概览
简要总结
The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants two year after program completion compared to before they took part in the program.
The main questions it aims to answer are:
- Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels after SSBC program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)?
- Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics (weight and waist circumference) after program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)?
- Are eating motives associated with dietary intake in individuals with prediabetes?
- Does participation in SSBC result in changes to eating motives over time?
It is hypothesized that:
- Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months post-intervention.
- Dietary changes will be associated with weight and waist circumference at 3-, 6-, and 12-months post-intervention.
- Participants' eating motives are associated with their dietary intake.
- Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post intervention.
A total number of 250 individuals with prediabetes will be recruited to take part in a 6-week diet and exercise changes program (SSBC). The program will be administered and facilitated by the community facility trainers at YMCA locations. Participants will be asked to visit Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.
详细描述
The study is a one-group repeated measures design and the primary outcome is hemoglobin A1c% (HbA1c%). There is no randomization of individuals to conditions. HbA1c will be measured using point-of-care test at eight timepoints. Secondary outcomes include diet (caloric, carbohydrate and fibre intake), anthropometrics (weight and waist circumference) and eating motives.
Objectives:
Given the importance of diet for HbA1c% improvement among those at risk of developing type 2 diabetes (T2D), the purpose of this study is to assess caloric, carbohydrate and fibre intake in real-life settings and evaluate whether these dietary factors predict HbA1c levels over 24 months. Second, the researchers aim to investigate whether dietary changes predict weight and waist circumference among the study participants. Further, food choices are determined by many factors, including but not limited to biological, physiological, psychological and socio-cultural factors. Subsequently, the investigators aim to explore whether participants' motives for eating affect their dietary intake, and whether such motives change after partaking in SSBC.
Sample Size:
A total sample size of 214 is required to detect an HbA1c change between the baseline and the three follow-up segments. Linear trajectory was assumed between baseline and the 9-12-month segment, then a stable trajectory to the 21-24 month segment. The trial is powered to detect a clinically significant change across all segments. As such, the study is powered to detect the smallest expected change in HbA1c, which occurred at the 3-6 month segment based on the Phase IV effectiveness findings (d = .23) based on a previous RCT. Using G*Power, an initial sample size of N = 178 was calculated assuming two-sided type-I error probability of 5% and a power of 80%, d = .23 change in HbA1c at 3-6 months, and three covariates (age, sex, gender). Informed by Phase IV trial statistics, the investigators increased the sample to account for a <17.2% loss to follow-up (178/.828 = 214). The community partner agreed to deliver SSBC program to up to 250 individuals. Accordingly, 250 patients will be recruited.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults over the age of 18 and able to read and speak English
- •living with prediabetes: HbA1c% values between 5.7-6.4% (American Diabetes Association, 2012), or
- •individuals diagnosed with type 2 diabetes in remission, defined as achieving HbA1c of < 6.4% without any diabetes-related medications for a minimum of 3 months (Diabetes Canada Clinical Practice Guidelines, 2022), or
- •individuals at high risk of developing type 2 diabetes defined as an American Diabetes Association risk questionnaire score ≥ 5.
排除标准
- •failure to obtain participant's signed declaration for the Get Active questionnaire
- •currently diagnosed with type 2 diabetes with an HbA1c of 6.5% or greater
结局指标
主要结局
change in hemoglobin A1c% (HbA1c%)
时间窗: 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.
HbA1c% provides a measure of the average glucose concentration over the past three months.
次要结局
- change in waist circumference (inches)(7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups)
- change in weight (lbs)(7 timepoints: at baseline (month 0), and 3-,6-,9-,12-, 21-and 24-month follow-ups)
- change in fibre intake (grams)(5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups)
- change in carbohydrate intake (grams)(5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups)
- change in caloric intake (kcal)(5 timepoints: at baseline (0), immediate post program (after session 6) and 3-,6- and 12- month follow ups)
研究者
Mary Jung
Associate Professor
University of British Columbia