Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Feasibility (Recruitment)
研究概览
简要总结
This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1) evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a behavioral intervention for overweight or obese patients with type 2 diabetes that takes stress and well-being into consideration, 3) evaluate appropriateness of research procedures and measures, 4) examine effect size estimates of key outcomes to provide essential data to inform a larger efficacy trial, 5) determine whether clinically significant improvements occurred in any key outcomes.
详细描述
Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes clinics. Physicians will screen every patient attending to each clinic during the enrollment period for the presence of main eligibility criteria. Those patients who appear to be eligible will be introduced to the study and referred to a researcher for a more in-depth screening evaluation. Eligible patients who are interested in participating in the study will be asked to sign the informed consent. Consecutive patients will be randomly assigned in a 1:1 ratio to an experimental group or a control group. During the first month, participants in the experimental group will receive a well-being promoting intervention in adjunction to the treatment as usual (TAU), while those in the control group will be asked to follow the TAU. In the following 3 months participants in both groups will receive the small change intervention in adjunction to the the TAU. All in person sessions of the intervention will take place in an office of both the 2 diabetes clinics involved. Data about psychological and clinical variables will be collected for each participant through questionnaires and interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up. Participants' weight will be measured at each assessment point using a scale. Medical charts will be accessed to collect further data about physiological parameters, treatment received and medical history.
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
- Single (Outcomes Assessor)
盲法说明
A researcher adequately trained in the administration of questionnaires and interviews, and blinded to the experimental allocation of patients, will carry out all the evaluations.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 25;
- •Age ≥ 18;
- •Diagnosis of type 2 diabetes;
- •Fluent English or Italian.
排除标准
- •Inability to provide informed consent to participate in the study for any reason, including cognitive impairment and psychiatric illness;
- •Presence of any medical condition that would make participation in the study difficult and/or unsafe;
- •Presence of any medical condition associated with unintentional weight loss or gain;
- •Presence of untreated, severe and/or recently diagnosed (≤ 6 months) mental illness and/or presence of a severe personality disorder;
- •History of eating disorders and/or substance abuse;
- •Use of drugs for weight loss;
- •Participation in another weight loss program or in any other trial;
- •Participation in an individual or group psychological intervention;
- •Weight loss surgery within the year;
- •Pregnant or are planning to become pregnant within the year
- •Inability to control meal contents (e.g. institutionalized patients).
研究组 & 干预措施
Well-being and small change
Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
干预措施: Well-being intervention (Behavioral)
Well-being and small change
Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
干预措施: Small change intervention (Behavioral)
Small change
Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
干预措施: Small change intervention (Behavioral)
Small change
Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
干预措施: Treatment as usual (Other)
Well-being and small change
Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Feasibility (Recruitment)
时间窗: Baseline
Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).
Feasibility (Retention)
时间窗: Through study completion, intended to be 16 months
Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).
Feasibility (Acceptability of Intervention)
时间窗: Post-intervention, intended to be 4 months
Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.
次要结局
- Change in Psychological Distress(Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention)
- Change in Psychological Distress and Well-Being(Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention)
- Change in Psychological Well-Being(Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention)
- % Weight Change(Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention)
研究者
Chiara Rafanelli
Professor of Clinical Psychology
University of Bologna