- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01997697
Reduction of Emotional Eating After a Behavior Change Program in Obesity
Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.
연구 개요
상세 설명
While emotional eating, food intake in response to emotions, can be modulated by physical activity, the practice of that latter is difficult mostly in people with overweight. Thus, there is a need to adapt the practice of physical activity in function of the motivation of the individual. One of most prominent theoretical model is the transtheoretical model. Regarding changes in physical activity and eating behavior, some data suggest that the processes of change from the transtheoretical model predict the efficacy of a treatment and thus its therapeutic success. The motivational approach could lead to self-regulation of emotions and therefore a decrease in emotional eating. Methods The study is a prospective cohort. Participants are exposed to a five-days hospitalization and engaged in a program of therapeutic education. During this hospitalization, there are some collective and individuals workshop on topics related to physical activity and nutrition. Intervention The intervention is based on the processes of change from the transtheoretical model. There are 5 experiential and 5 behavioral processes of change. Thus, according to the response of a questionnaire evaluating these processes of change, participants will be proposed some individualized strategies. Types of intervention Depending on scores of motivation, the following strategies will be proposed to participants.
- identify the barriers related to physical activity
- increase informations related to physical activity and nutrition
- informations about the risk related to inactivity and diet
- ask to the individual to list and barriers related to barriers as thhe interest to modify the behavior.
- List persons who may act as social support
- set behavior change goals
- Increase self-confidence and self-efficacy about changing behavior
- Relaxation at home
- Use reinforcement management
- methods of time management
- counter-conditioning
identify factors related to the relapse Time management Participants will be evaluated after the first 6 months. Then, they will be followed during 24 months. Statistical analysis Sample size The sample was calculated using a previous study. To obtain a difference of 0.51 in emotional eating with a standard deviation of 1.63 with an alpha risk of 5% and a power of 90%, the number of subject is 110 subject. Expected a drop-out of 20%, 138 subjects will be included. Predictive factors
- Identification of predictive factors Student T test to select the predictive factors
- Predictive factors Multiple linear regression
- Mechanisms analysis of mediation with the Baron and Kenny method
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Montpellier, 프랑스, 34295
- University Hospital of Montpellier-Hopital La colombière
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with obesity (grade 2 or 3)
- Age 18 to 65
- participation to the therapeutic training
- Patient with non physical activity
Exclusion Criteria:
- Patients needing chirurgigical act
- patient taking neuroleptic or psychiatric
- pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Patients with obesity
behavior change program among patients with obesity
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behavior change program among patients with obesity
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Emotional eating assessed by the Dutch Eating behavior questionnaire
기간: 6 months
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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