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

NCT03167489 | Unknown

• 1 other identifier: 5579-HMO-CTIL
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases; Lifestyle Risk Reduction

Outcome Measures

Primary Outcomes (1)

• Mediterranean Diet Adherence

  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).

  5 months after intervention initiation

Secondary Outcomes (8)

• Pedometer Steps

  5 months after intervention initiation

• Body Mass Index

  5 months after intervention initiation

• Blood Pressure

  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

Study Arms (1)

Lifestyle Plus Emotional Regulation

EXPERIMENTAL

The core intervention will last 5 months. Nutrition content: Mediterranean diet education, social support, self-regulation techniques, and environmental support. Physical activity content: education, guidance in starting a routine, and a walking program with pedometers, weekly physical activity tips and step goals. Emotion regulation content: based on Dialectical Behavior Therapy adapted to binge eating disorders and other ER sources, emphasizing identifying emotions, recognizing the causes of emotions, accepting and tolerating negative emotions, effective self-support and self-compassion, 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.

Behavioral: Lifestyle Plus Emotional Regulation

Interventions

Lifestyle Plus Emotional Regulation BEHAVIORAL

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

Lifestyle Plus Emotional Regulation

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

Related Publications (6)

• Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.

  PMID: 10882764 BACKGROUND

• Roosen MA, Safer D, Adler S, Cebolla A, van Strien T. Group dialectical behavior therapy adapted for obese emotional eaters; a pilot study. Nutr Hosp. 2012 Jul-Aug;27(4):1141-7. doi: 10.3305/nh.2012.27.4.5843.

  PMID: 23165554 BACKGROUND

• Neamah HH, Sebert Kuhlmann AK, Tabak RG. Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Diabetes Educ. 2016 Apr;42(2):153-65. doi: 10.1177/0145721716630386. Epub 2016 Feb 15.

  PMID: 26879459 BACKGROUND

• Eckert M, Ebert DD, Lehr D, Sieland B, Jazaieri H, Berking M. Teachers' Emotion Regulation Skills Facilitate Implementation of Health-related Intentions. Am J Health Behav. 2015 Nov;39(6):874-81. doi: 10.5993/AJHB.39.6.15.

  PMID: 26450555 BACKGROUND

• Macht M, Simons G. Emotions and eating in everyday life. Appetite. 2000 Aug;35(1):65-71. doi: 10.1006/appe.2000.0325.

  PMID: 10896762 BACKGROUND

• Wallace LM, Masson PC, Safer DL, von Ranson KM. Change in emotion regulation during the course of treatment predicts binge abstinence in guided self-help dialectical behavior therapy for binge eating disorder. J Eat Disord. 2014 Dec 11;2(1):35. doi: 10.1186/s40337-014-0035-x. eCollection 2014.

  PMID: 25516798 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Donna R Zwas, MD

  Hadassah University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Model Details: This pilot study includes a within subjects, delayed intervention design.

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)