DiaMester: E-health Lifestyle Program for Improved Self-management and Remission of Type 2 Diabetes - a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in body weight from baseline (weight loss)
研究概览
简要总结
This registration covers a pilot for a 3-armed parallel-group randomized controlled trial (RCT) that will evaluate the efficacy of DiaMester, a Norwegian e-health programme designed to improve self-management and induce clinically meaningful weight loss, and thereby potential remission in adults with type 2 diabetes (T2D).
详细描述
The aim of this pilot RCT is to test the feasibility of the program and to investigate to what extent the program contributes to the intended improvement in lifestyle, self-management, metabolic risk factors and body weight. We also aim to investigate if participants in the e-health program achieve a clinically meaningful weight loss in each of the two intervention arms: one including a low-calorie diet (LCD) total diet replacement (TDR) induction phase and one without the use of a LCD.
The DiaMester app serves as a secure communication platform between each participant and an assigned health coach, who provides individually tailored advice on diet and physical activity and monitors progress towards agreed weight-loss targets. Six health coaches (clinical dietitians or diabetes nurses) will deliver the intervention, each having completed the same standardized training prior to study start.
Hypotheses:
Primary objective: To test whether participation in the DiaMester e-health program with an LCD induction phase results in greater weight loss compared to usual care after 12 months.
H1: The e-health + LCD group will achieve greater weight loss after 12 months than the control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Written informed consent
- •Men and women aged ≥ 18 years
- •Type 2 diabetes of duration 0-6 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1c and/or blood glucose)
- •HbA1c ≥ 48 mmol/mol at the last routine clinical check, within last 12 months if on diet alone
- •HbA1c ≥ 43 mmol/mol if on treatment with oral hypoglycaemic agents or GLP-1 RA treatment
- •Body Mass Index (BMI) >27 kg/m2
- •Stable body weight during the last 6 months with or without the use of weight-reducing drugs
- •Self-reported desire to lose weight
- •Owns a smartphone
排除标准
- •Current insulin use
- •> 5% weight change or started treatment with weight reducing drugs* within the last 6 months. *orlistat (Xenical), bupropion-naltrekson (Mysimba), fenteramin-topiramat (Qsimba), semaglutid (Wegovy, Ozempic), tirzepatid (Mounjaro), liraglutid (Saxenda, Victoza), dulaglutid (Truicity).
- •Recent routine HbA1c ≥108 mmol/mol
- •Recent eGFR <30 ml/min/1.73 m^2
- •Known cancer
- •Myocardial infarction within previous 6 months
- •Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
- •Pregnancy/considering pregnancy or exclusively breastfeeding
- •Substance abuse (drugs, alcohol)
- •Diagnosed eating disorders or suspected ED based on screening questionnaire
- •Learning difficulties or unable to understand, speak and read Norwegian or English
- •Patients who have required hospitalization for depression or are on antipsychotic drugs
- •People currently participating in another clinical research trial
研究组 & 干预措施
3
Standard care, but with continuous glucose monitoring (CGM) for 10 days at baseline and 1 year.
1
E-health program with LCD
干预措施: e-health lifestyle program (Behavioral)
1
E-health program with LCD
干预措施: Low calorie diet (Behavioral)
2
E-health program without LCD
干预措施: e-health lifestyle program (Behavioral)
结局指标
主要结局
Change in body weight from baseline (weight loss)
时间窗: Body weight will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.
Body weight (kg) will be measured by the participants' GPs. Change in body weight will be reported as percentage weight loss and will be analysed as a continuous variable.
次要结局
- Change in HbA1c from baseline(HbA1c will be measured at baseline, 3 months, 6 months, 9 months and 12 months.)
- Change in blood lipids from baseline(Lipids will be measured at baseline, 6 months and 12 months)
- Change in blood pressure from baseline(Blood pressure will be measured at baseline, 3 months, 6 months, 9 months and 12 months.)
- Change in blood glucose time in range from baseline(Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year.)
- Change in average blood glucose baseline(Participants' in the control group will wear a CGM for 10 days at baseline and 1 year, while participants' in the two intervention groups will wear a CGM for 40 days at baseline, 40 days at 6 months and 10 days at one year.)
- Change in use of medications from baseline(Use of medications will be assessed at baseline, 3 months, 6 months, 9 months and 12 months.)
- Change in diet quality from baseline(Diet quality will be assessed at baseline, 6 months and 1 year.)
- Change in physical activity from baseline(Physical activity will be assessed at baseline and 1 year follow up.)
- Change in health related quality (HRQoL) of life from baseline(Measured at baseline and 1 year follow-up)
- Change in diabetes distress of life from baseline(Measured at baseline and 1 year follow-up)
- Change in diabetes self-management from baseline(Measured at baseline and 1 year follow-up)
- Change in eating disorder symptoms from baseline(Measured at baseline and 1 year follow-up)
- Prevalence of likely eating disorder at baseline(Measured at baseline)
研究者
Anne-Marie Aas
Associate Professor and Clinical Dietitian
Oslo University Hospital