The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:
- effect on anthropometric measurements
- effect on lipid profile
- effect on weight-related quality of life
- observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.
- Intervention group: They were given a calorie-restricted diet and exercise plan by a dietician or physiotherapist at their first visit, and were followed up by telephone calls at weeks 2, 4, 6, 8 and 10 over 12 weeks.
- Control-1 group: During the initial medical interview, the participants were given a calorie-restricted diet programme by a dietician and an exercise programme by a physiotherapist; they were followed up over 12 weeks with telephone calls at week 4.
- Control-2 group: The participants were not provided with any programme, and the importance of weight loss was emphasised by the family physicians. Dietary and physical activity advice was given according to the recommendations in the Turkish Endocrine and Metabolism Association 2019 Obesity Diagnosis and Treatment Guide, and was followed up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks.
详细描述
With this study, it is aimed to evaluate the effect of intensive lifestyle intervention to be applied to patients and follow-ups made by telephone calls in order to protect overweight and obese patients who apply to primary health care services from obesity and complications of obesity in the pandemic process in which the number of applications to secondary and tertiary care decreased due to pandemic conditions and the number of applications to primary care increased, in addition to this, the susceptibility to obesity increased due to changing lifestyle behaviours with the effect of the pandemic; The aim of this study is to evaluate the effect of intensive lifestyle intervention and telephone follow-ups on body mass index, body composition, lipid profile, obesity-related quality of life and to evaluate different forms of intervention organised as intensive lifestyle intervention and increasing the frequency of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 BMI ≥ 25 kg/m 2 Agreeing to participate in the study Not having a diagnosed chronic disease To be able to ambulate To be cooperative
排除标准
- •Receiving medical treatment
- •Secondary obesity (hypothyroidism, Cushing's disease, etc.)
- •Chronic disease (cardiovascular diseases, pulmonary diseases, presence of diabetes mellitus, liver diseases, renal diseases)
- •Having hyperlipidaemia under treatment
- •Pregnancy or breastfeeding
- •Psychiatric disorder
- •Orthopaedic or neurological disease that may prevent walking
- •Are currently taking weight loss medication or enrolled in another weight loss program
- •Having previously undergone obesity surgery or having surgery planned during the study period
结局指标
主要结局
Primary Outcome
时间窗: 3 months
Turkish version of the Impact of Weight on Quality of Life-Lite Version (IWQOL) scale was used. The scale has a minimum score of 0 and a maximum of 100. The scoring system is valid for both the scale subgroups and the scale total score. Based on the scale scoring, quality-of-life decreases as the score decreases.
次要结局
- Secondary(3 months)
- BMI (kg/m2)(3 months)
- Waist Circumference (cm)(3 months)
- Lipid Profile(3 months)
研究者
Duygu Ayhan Baser
Assoc Prof
Hacettepe University