Clinical trial NCT03167489: Lifestyle Intervention Plus Emotion Regulation Group Intervention Impact on Women's Cardiovascular Risk Reduction
Official title: Impact of Lifestyle Intervention Plus Emotion Regulation Group Intervention on Cardiovascular Risk Reduction in Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiovascular Diseases
Lifestyle Risk Reduction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 400
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study includes a within subjects, delayed intervention design.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mediterranean Diet Adherence
timeFrame: 5 months after intervention initiation
Secondary outcomes:
measure: Pedometer Steps
timeFrame: 5 months after intervention initiation
measure: Body Mass Index
timeFrame: 5 months after intervention initiation
measure: Blood Pressure
timeFrame: 5 months after intervention initiation
measure: Hemoglobin A1c, plasma levels of HDL, LDL, triglycerides, and total cholesterol
timeFrame: 5 months after intervention initiation
measure: Emotional Regulation Skills
timeFrame: 5 months after intervention initiation
measure: Eating Behavior
timeFrame: 5 months after intervention initiation
measure: Healthy Heart Score
timeFrame: 5 months after intervention initiation
measure: Binge Eating Behavior
timeFrame: 5 months after intervention initiation
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah University Medical Center
name: Donna R Zwas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
citation: Macht M, Simons G. Emotions and eating in everyday life. Appetite. 2000 Aug;35(1):65-71. doi: 10.1006/appe.2000.0325.
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.