Lifestyle Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Weight maintenance 12 months after weight loss intervention
研究概览
简要总结
Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research.
In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points.
At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants.
At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling.
Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss.
Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.
详细描述
Step I - Screening and baseline phenotyping When a potential suitable participant is interested, a screening interview to check eligibility will take place by phone after oral agreement is given. The structured screening interview is carried out by means of a questionnaire in the format of a Case Report Form (CRF). Suitable persons are provided with participant´s information and data protection sheet and with the "declaration of consent". Sufficient time for consideration is given between the screening interview and visit 1A, where written consent is signed.
After the telephone-based screening interview, eligible participants are required to provide written consent. Participants will undergo clinical examinations at two visits (V1A + V1B), serving primarily for phenotyping as well as for detection of potentially unknown exclusion criteria. The order of some measurements carried out during V1A and V1B as well as the type of lipid challenge is randomized.
Data collection V1A:
- Resting metabolic rate
- Metabolic response to meal challenge
- Anthropometry
- Vital parameters
- Blood parameters
- Clinical, lifestyle (nutrition, physical activity), psychological, environmental and social factors (questionnaires and protocols)
- Sampling of blood samples for further research questions
Data collection V1B:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 65 years
- •BMI: 30,0 - 39,9 kg/m2
- •Owner of a smartphone
- •Caucasian
- •No severe diseases
- •Informed written consent
排除标准
- •Diabetes mellitus
- •Severe cardiovascular and/or respiratory disease
- •Untreated high blood pressure
- •Severe kidney disease
- •Active cancer (or in remission)
- •Inflammatory bowel disease
- •Severe chronic infections and/or inflammations
- •Severe mental-health disorders
- •Neurodegenerative disorders
- •Endocrine diseases
- •Pregnancy and lactation
- •Vigorous weight fluctuations (> 5 kg) in the last 3 months
- •Immobility
- •Surgery in the last 3 months
- •Participation in other intervention studies
- •Carrier of pace makers
- •Blood donation or transfusion in the last 3 months
结局指标
主要结局
Weight maintenance 12 months after weight loss intervention
时间窗: 15 months
Body weight change in kg and % (from baseline weight)
次要结局
- Glucose response on meal challenges(month 0)
- Weight change after eight weeks of formula diet(month 3)
- Glucose(month 0, 3, 6, 9, 12, 15, 27)
- Insulin(month 0, 3, 6, 9, 12, 15, 27)
- Lipids(month 0, 3, 6, 9, 12, 15, 27)
- Leptin(month 0, 3, 6, 9, 12, 15, 27)
- Resting metabolic rate(month 0, 3, 15, 27)
- Magnetic resonance imaging (MRI)(month 0, 3, 15, 27)
- Insulin response on meal challenges(month 0)
- Lipid response on meal challenges(month 0)
研究者
Christina Holzapfel
Principal investigator
Technical University of Munich