Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial

NCT01861977 | Completed DMC

• 1 other identifier: 2009
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effectiveness of a program to improve habits in a population with cardiovascular disease, comparing two different educational techniques (cognitive behavioral therapy group vs. informational workshops).

Conditions

Health Behavior; Motor Activity; Food Habits

Keywords

Cognitive Therapy; Health Education; Secondary Prevention; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Achievement of moderate physical activity recommendations

  Moderate physical activity: minutes per week measured by the questionnaire WHO STEP wise (Physical activity at work/in the household, for transport and during leisure time; minimum 0; the grater the better).

  One year

• Consumption of fruits and vegetables

  Consumption of fruits and vegetables: number of servings per day measured by questionnaire WHO STEP wise (minimum 0; optimal 5 or more).

  One year

Secondary Outcomes (4)

• Smoking cessation

  One year

• Blood pressure control

  One year

• Lipid Control

  One year

• Body weight reduction

  One year

Other Outcomes (2)

• Improvement in health related quality of Life

  One year.

• Treatment Adherence

  One year

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.

Behavioral: Cognitive Behavioral Therapy

Informational Workshop

ACTIVE COMPARATOR

Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.

Behavioral: Informational Workshop

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.

Cognitive Behavioral Therapy

Informational Workshop BEHAVIORAL

Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.

Informational Workshop

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers.
• and
• Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work).

You may not qualify if:

• \- Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution.
• Moderate or severe limitation on functional capacity and / or mobility. or
• Patients with dementia. or
• Patients diagnosed with psychiatric illnesses that compromise patient autonomy. or
• Life expectancy less than 1 year. or
• Patients who do not want to take part in the program. or
• Patients who are participating in another research protocol at recruitment. or
• Patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Location

Related Publications (11)

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  PMID: 15364186 BACKGROUND

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  PMID: 1686830 BACKGROUND

• Ismail K, Winkley K, Rabe-Hesketh S. Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. Lancet. 2004 May 15;363(9421):1589-97. doi: 10.1016/S0140-6736(04)16202-8.

  PMID: 15145632 BACKGROUND

• Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106.

  PMID: 12813116 BACKGROUND

• Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.

  PMID: 21263103 BACKGROUND

• Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. J Am Coll Cardiol. 2011 Nov 29;58(23):2432-46. doi: 10.1016/j.jacc.2011.10.824. Epub 2011 Nov 3. No abstract available.

  PMID: 22055990 BACKGROUND

• Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil-Smoller S, Turan TN, Wentworth D; American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. Stroke. 2011 Jan;42(1):227-76. doi: 10.1161/STR.0b013e3181f7d043. Epub 2010 Oct 21.

  PMID: 20966421 BACKGROUND

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.

  PMID: 20668659 RESULT

• Barth J, Schneider S, von Kanel R. Lack of social support in the etiology and the prognosis of coronary heart disease: a systematic review and meta-analysis. Psychosom Med. 2010 Apr;72(3):229-38. doi: 10.1097/PSY.0b013e3181d01611. Epub 2010 Mar 11.

  PMID: 20223926 RESULT

• Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.

  PMID: 16263889 RESULT

MeSH Terms

Conditions

Health Behavior; Motor Activity; Feeding Behavior; Health Education; Cardiovascular Diseases

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gaston Perman, MD, MSc

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

• Gabriela Buela, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Programs

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 24, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

AR (1)