Effect of Mindful Eating on Weight Management in Breast Cancer Survivors

NCT03972540 | Completed

• 1 other identifier: STUDY00002818
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.

Conditions

Breast Neoplasm Female

Keywords

Obesity; Mindful eating; Postmenopausal breast cancer survivors; Weight management; Cardiovascular health

Outcome Measures

Primary Outcomes (6)

• Body Mass Index

  At the baseline and follow-up visits, trained study staff measured participants' weight and height using a standardized protocol. Height (measured by a stadiometer to the nearest 0.1 cm) and weight (measured by a scale to the nearest 0.1 kg) was used to calculate BMI (weight in kg divided by height in m²).

  Change measured between weeks 1 and 12

• Blood Pressure

  At the baseline and follow-up visits, trained study staff measured participants' systolic/diastolic blood pressure using a standardized protocol to the nearest mmHg. In order to ensure reliability, all measurements were taken 3 times and average values were used for analyses.

  Change measured between weeks 1 and 12

• Waste and Hip Circumference

  At the baseline and follow-up visits, trained study staff measured participants' waist and hip circumference by tape measure to the nearest 0.1 centimeter.

  Change measured between weeks 1 and 12

• Body Fat Percentage

  At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).

  Change measured between weeks 1 and 12

• Feasibility of Conducting the Intervention

  Feasibility was assessed by tracking participant accrual and retention rates.

  Measured at week 12

• Acceptability of the Intervention

  To measure acceptability, participants were asked to complete a 5-question feedback survey to evaluate the mindful eating intervention at the follow-up study visit. Specifically, the open-ended survey questions asked participants about (1) their experience with intervention, (2) how the intervention affected diet and exercise management, (3) positive aspects about the intervention, (4) negative aspects about the intervention, and (5) suggested changes to the intervention. Qualitative data analysis techniques were used to identify themes within the data.

  Measured at week 12

Secondary Outcomes (1)

• Mindful Eating Measures

  Change measured between weeks 1 and 12

Other Outcomes (2)

• Nutritional Intake

  Change measured between weeks 1 and 12

• Physical Activity

  Change measured between weeks 1 and 12

Study Arms (1)

Mindful eating intervention

EXPERIMENTAL

The mindful eating intervention was taught by a mindfulness-based stress reduction instructor certified by the Center of Mindfulness at the University of Massachusetts Medical School.

Behavioral: Mindful eating intervention

Interventions

Mindful eating intervention BEHAVIORAL

A Mindful Eating Workshop™ workbook was used for standardization and reproducibility of these sessions. The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food. Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks. The intervention was delivered in a large conference room on the University of Georgia campus. Participants were required to attend seven out of eight sessions. If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session.

Mindful eating intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal female
• Breast cancer survivor (in remission)
• Completed cancer treatment at the time of study enrollment
• Body Mass Index (BMI) equal or greater than 25 kg/m²

You may not qualify if:

• None.

Sponsors & Collaborators

• University of Georgia: lead

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 3, 2019
• Study Start: May 9, 2016
• Primary Completion: July 29, 2016
• Study Completion: October 31, 2016
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share