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Lifestyle Intervention Plus Emotion Regulation Group Intervention Impact on Women's Cardiovascular Risk Reduction

NCT03167489 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-04-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Lifestyle Plus Emotional Regulation

Group intervention over 5 months, integrating the Mediterranean Diet into a lifestyle intervention and emotional regulation skills.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Donna R Zwas, MD · Hadassah University Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167489 on ClinicalTrials.gov