Mindful Eating and Living for Obese Women

NCT02753972 | Terminated

• 1 other identifier: HRRC#: 06-254
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Mindfulness-based interventions may be effective in reducing the stress that may increase both obesity and inflammation. Purpose: The purpose of this study was to examine the effects of a mindful eating intervention on weight loss and health-related outcomes. Methods: Thirty-six obese, postmenopausal women were randomized to a six-week Mindful Eating and Living (MEAL) intervention or an active control group (CONT) consisting of nutritional counseling, goal setting, and group support. Weight, body mass index (BMI), waist-hip ratio (WHR), binge eating, interleukin-6 (IL-6) and C-reactive protein (CRP) were assessed at baseline and four follow-up periods up to one year. Results: Multilevel analyses showed that the MEAL group had reductions in weight, BMI, WHR, binge eating, IL-6, and CRP; the CONT group had reductions in weight, BMI, and binge eating. The reductions in binge eating, IL-6, and CRP were greater for the MEAL as compared with the CONT group. Conclusions: This study suggests that a mindfulness-based eating intervention may promote weight loss and reduce a variety of health-related risk factors in post-menopausal women who are obese.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Decreases in body mass index

  Baseline, 6 month, 4 months, 9 months, 1 year

Study Arms (2)

Mindful Eating and Living

EXPERIMENTAL

The goal of the Mindful Eating and Living (MEAL) intervention was to apply mindfulness to apply mindfulness to eating behavior. The content for the MEAL sessions included group discussion, mindfulness meditation, and group eating exercises. The course, based on the work of Kristeller, Baer, \& Quillian-Wolever (31), emphasized brief daily meditation and pairing meditation with eating, but was more streamlined in terms of didactic content and course length. Participants examined hunger and satiety cues, the qualities of foods they crave, and emotional and cognitive states associated with eating. Each session included an eating exercise with a variety of foods. The monthly refresher sessions included a brief meditation, a brief eating exercise, and group discussion. (The MEAL curriculum is available from the authors.)

Behavioral: Mindful Eating and Living

Active Control

ACTIVE COMPARATOR

The Active Control (CONT) group matched the MEAL group regarding schedule. The agenda for the CONT sessions involved giving each participant the opportunity to discuss issues such as food choices, activity levels, and caloric goals. The sessions began by having the participants check-in about their experiences with eating. Next, the clinical psychology graduate student led the participants in goal setting and finally there was a question and answer period when the registered dietician answered questions about food selection. The monthly refresher sessions had the same agenda as the initial weekly sessions.

Behavioral: Active Weight Loss Control

Interventions

Mindful Eating and Living BEHAVIORAL

8 week mindfulness skills intervention

Mindful Eating and Living

Active Weight Loss Control BEHAVIORAL

8 week active weight loss control group

Active Control

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women between the ages of 55 and 70 without untreated medical illness
• Fluency in the English language
• Body mass index (BMI) ≥30 kg/m2
• Able to walk for at least 10 minutes without needing to stop or without symptom onset

You may not qualify if:

• Significant untreated medical illness as evidenced by abnormal electrolytes or liver function tests
• Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than or equal to 95 mmHg with or without treatment
• Abnormal thyroid stimulating hormone
• Abnormal late night salivary cortisol
• Untreated diabetes mellitus
• Any severe psychiatric condition
• Loss or gain of greater than or equal to 4 pounds in the past 6 months
• Pharmacologic treatment for weight loss within three months before screening
• Treatment with a very low calorie diet within six months before screening
• Use of systemic corticosteroids within three months
• Use of neuroleptic agent within three months
• Treatment for eating disorder within five years
• Diagnosis of a malignant disease except basal cell carcinoma within five years
• Change in smoking status within three months or during course of study
• Any condition that may preclude informed consent

Sponsors & Collaborators

• University of New Mexico: lead
• National Center for Research Resources (NCRR): collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Practice Physician

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 28, 2016
• Study Start: August 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share