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临床试验/NCT03167489
NCT03167489Enrolling By Invitation不适用

Impact of Lifestyle Intervention Plus Emotion Regulation Group Intervention on Cardiovascular Risk Reduction in Women: A Pilot Study

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
试验地点
2
主要终点
Mediterranean Diet Adherence

研究概览

简要总结

This pilot study aims to demonstrate that emotional regulation (ER) is a valuable supplement to a documented and effective group-based lifestyle intervention on cardiovascular disease risk reduction maintenance in a non-clinical population by assessing changes in this primary outcome: Mediterranean diet adherence and these secondary outcomes: average daily steps, METS per week, BMI, blood pressure, physical activity, LDL, HDL, Triglycerides, Hemoglobin A1c, Western Diet Score, ER skills, Healthy Heart Score and eating behavior. This study will include women aged 35-75 and the group intervention will be based on the gold standard Diabetes Prevention Study, integrating the Mediterranean Diet as well as emotional regulation skills based on dialectical behavior therapy. The core intervention will last 3 months with 2 booster sessions will be conducted over 1 month.

详细描述

Group lifestyle interventions (LI) have documented efficacy in improving cardiovascular disease (CVD) risk factors, however, many fail to demonstrate outcome maintenance. Existing LIs primarily focus on behavioral regulation, neglecting to address emotional regulation (ER). Difficulty with negative emotions often leads to unhealthy lifestyle recidivism, particularly in women, whereas acquiring ER skills have been found to improve healthy eating and is associated with increased physical activity. The effectiveness of ER as a healthy eating intervention has been documented in individuals with binge eating disorders and obese emotional eaters; however, it has never been utilized in a non-clinical population.

This pilot study aims to demonstrate that emotional regulation (ER) is a valuable supplement to a documented and effective group-based lifestyle intervention on cardiovascular disease risk reduction maintenance in a non-clinical population by assessing changes in this primary outcome: Mediterranean diet adherence and these secondary outcomes: average daily steps, METS per week, BMI, blood pressure, physical activity, LDL, HDL, Triglycerides, Hemoglobin A1c, Western Diet Score, ER skills, Healthy Heart Score and eating behavior. This study will include females and the group intervention will be based on the gold standard Diabetes Prevention Program, integrating the Mediterranean Diet as well as emotional regulation skills based on dialectical behavior therapy. The intervention will take place over 4 months: a weekly core intervention over 3 months time and 2 booster sessions over 1 month time.

Intervention:

Group sessions will focus on adherence to the Mediterranean Diet and increased physical activity. Nutrition content will include diet education, group counseling and social support, food interaction (tasting and cooking), behavioral self-regulation techniques (goal setting, self-monitoring, planning), conscious eating, creating healthy environmental support, and guidance tailored to the target audience. Physical activity will include education, motivation, guidance in starting a routine, and an experiential aerobic exercise class. Participants will be encouraged to exercise at least 150 minutes per week. Physical activity will also be integrated into sessions through a walking program, where participants receive a pedometer, weekly physical activity encouragement and tips, and create weekly step goals. Weekly steps will be tabulated by group leaders and assistants through pedometer measurement.

The emotion regulation skills modules will be modified from the Dialectical Behavior Therapy manual adapted to binge eating disorders (DBT-BED) and other ER sources. These modules will emphasize ER skills that include the ability to identify and label emotions, to recognize their causes and what maintains emotions, the ability to accept and tolerate negative emotions, the skills to provide effective self-support and self-compassion in distressing situations, and the ability to manage situations that elicit negative emotions, as well as re-appraisal skills, which are identified as particularly influential on eating behaviors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 35-75, willingness to commit to participation in the lifestyle intervention and follow-up.

排除标准

  • Pregnancy, history of serious mental and physical illness, or other conditions that may impede or prohibit participation for the duration of the trial.

结局指标

主要结局

Mediterranean Diet Adherence

时间窗: 5 months after intervention initiation

The Mediterranean Diet (MD) is an eating style that emphasizes the consumption of fruits, vegetables, legumes, and whole grains as well as fish, wine, olive oil, and nuts. MD adherence will be assessed through a self-report questionnaire based on the ATTICA Study, adapted to the Israeli diet (Panagiotakos, Chrysohoou, Pitsavos, and Stefanadis, 2005).

次要结局

  • Pedometer Steps(5 months after intervention initiation)
  • Healthy Heart Score(5 months after intervention initiation)
  • Body Mass Index(5 months after intervention initiation)
  • Blood Pressure(5 months after intervention initiation)
  • Eating Behavior(5 months after intervention initiation)
  • Binge Eating Behavior(5 months after intervention initiation)
  • Hemoglobin A1c, plasma levels of HDL, LDL, triglycerides, and total cholesterol(5 months after intervention initiation)
  • Emotional Regulation Skills(5 months after intervention initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donna R Zwas

Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Hadassah Medical Organization

研究点 (2)

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