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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03167489
• Other study ID #: 5579-HMO-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Maintenance preparation sessions will address behavioral change maintenance, obstacle identification and coping skills. The booster session will provide an overview of the intervention and plans for continued outside-intervention support.

Data will be collected at baseline and 2 post intervention follow up points (after the first 4 months and 6 months following).

Control:

There will be a delayed treatment control for this pilot, wherein participants who enlist to the study will be asked complete baseline questionnaires at enlistment date, 4 months later (at the start of the intervention) and then, at the 2 post intervention data points.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lifestyle Risk Reduction

Intervention

Behavioral:
• Lifestyle Plus Emotional Regulation
Group intervention over 5 months, integrating the Mediterranean Diet into a lifestyle intervention and emotional regulation skills.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pedometer Steps	Participants will be provided with a pedometer (Omron Model HJ-320) and will be encouraged to wear it throughout the program. Omron pedometers have been shown to demonstrate validity and reliability at various mounting positions in both healthy and overweight adults49. Measures will include average daily steps, as an objective measure of physical activity, and percentage change in steps, as an objective measure of change in physical activity level.	5 months after intervention initiation
Secondary	Body Mass Index	Weight will be measured in kilograms using a standardized, calibrated scale and height will be measured using a standardized stadiometer. Weight loss in kilograms and percent weight loss will be calculated. BMI will be calculated by body weight /height2, and change in BMI will be calculated.	5 months after intervention initiation
Secondary	Blood Pressure	Blood pressure will be measured using standard procedures with an electronic BP apparatus and the recorded measurement will be the average of 2 measurements taken in the seated position .	5 months after intervention initiation
Secondary	Hemoglobin A1c, plasma levels of HDL, LDL, triglycerides, and total cholesterol	Hemoglobin A1c, plasma levels of HDL, LDL, triglycerides, and total cholesterol will be measured using capillary whole blood obtained on finger stick, through hospital and national health management organizations' laboratories.	5 months after intervention initiation
Secondary	Emotional Regulation Skills	The Difficulties in Emotion Regulation Scale-16 (DERS-16) is a brief measure of emotion regulation difficulties. This scale demonstrates good internal consistency, test-retest reliability, as well as convergent and discriminant validity.	5 months after intervention initiation
Secondary	Eating Behavior	The Dutch Eating Behavior Questionnaire (DEBQ) is a measure of Restrained, External, and Emotional eating. This questionnaire has good internal consistency and factorial validity as well as predictive validity for food consumption.	5 months after intervention initiation
Secondary	Healthy Heart Score	The Healthy Heart Score is a lifestyle-based CVD prediction model that was developed using health data from 61,025 women in the Nurses' Health Study and 34,478 men in the Health Professionals Follow-up Study, who were free of chronic disease in 1986 and followed for CVD for up to 24 years. The Healthy Heart Score is based on the diet and lifestyle factors that include smoking, weight, exercise, and intake of alcohol, fruits and vegetables, whole grains, nuts, sugary beverages, and red and processed meat. On a prospective study, women with higher predicted CVD risk based on the Healthy Heart Score had an 18-fold higher risk of type 2 diabetes mellitus,5-fold higher risk of hypertension, and 3-fold higher risk of hypercholesterolemia during 20 years.	5 months after intervention initiation
Secondary	Binge Eating Behavior	Binge eating behavior will assesses using items 13, 14 and 15 of the Eating Disorders Examination - Questionnaire (EDE-Q), as has been done previously by Goldfein and colleagues (Goldfein, 2005). The EDE-Q is the most reliable and valid instrument for eating disorder assessment.	5 months after intervention initiation