Approaches for Improving Long-term Weight Loss

Sponsor
The Miriam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03799289
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
60
1
2
23.9
2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral weight loss followed by yoga instruction
  • Behavioral: Behavioral weight loss followed by cooking/dietary education instruction
N/A

Detailed Description

Behavioral weight loss (WL) programs result in clinically significant weight losses; however rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL success may require an enhanced ability to overcome physiological and hedonic urges to eat and an improved capacity for dealing with life stressors, negative mood states, and food cravings. Thus interventions which target stress reduction and reduce the tendency to use food as a coping strategy for aversive experiences may offer a protective effect against dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention which reduces stress and improves overall physical and psychological well-being and offers promise for strengthening the psychological skill set needed for maintaining important weight-related behaviors long-term. The physical and cognitive skills practiced within yoga target multiple underlying psychological processes (e.g., mindfulness, distress tolerance) which could reduce emotional eating, improve dietary choices, and enhance one's ability to tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach for other chronic health conditions, it has not been examined as a potential intervention for improving long-term WL outcomes. Within the context of the obesity field, yoga has been viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to many forms of aerobic exercise, the effect of yoga on important weight- related processes and behaviors has not been examined.

The primary aims of this study are to examine the feasibility and acceptability of implementing yoga within a weight management program. Secondary aims focus on examining the impact of yoga, relative to a cooking/dietary education intervention (matched for contact time) on important psychological constructs (perceived stress, mindfulness, and distress tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a 12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12 weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary assessments will occur at baseline and weeks 12 and 24.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss
Actual Study Start Date :
Jan 3, 2019
Actual Primary Completion Date :
Jun 18, 2020
Actual Study Completion Date :
Dec 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iyengar Yoga

Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral: Behavioral weight loss followed by yoga instruction
12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Active Comparator: Cooking/dietary education

Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral: Behavioral weight loss followed by cooking/dietary education instruction
12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Outcome Measures

Primary Outcome Measures

  1. Program Satisfaction Ratings [6 months]

    Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)

  2. Intervention Session Attendance [6 months]

    Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).

  3. Feasibility of the Intervention (Retention) [6 months]

    Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment

Secondary Outcome Measures

  1. Changes in Perceived Stress (Measured Via the Perceived Stress Scale) [Change from 12 to 24 weeks]

    Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.

  2. Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale [Change from 12 to 24 weeks]

    The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.

  3. Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale [Change from 12 to 24 weeks]

    The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.

  4. Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale [Change from 12 to 24 weeks]

    This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.

  5. Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale [Change from 12 to 24 weeks]

    This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.

  6. Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale [Change from 12 to 24 weeks]

    This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.

  7. Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) [Change from 12 to 24 weeks]

    The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.

  8. Change in Weight [Change from 12 to 24 weeks]

    Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • BMI 25-40 kg/m2

  • Female

Exclusion Criteria:
  • Presence of any condition that would limit one's ability to exercise or lose weight safely

  • Recent weight loss

  • Current or recent enrollment in a weight loss or mindfulness-based treatment program

  • Women who are pregnant or planning on becoming pregnant

  • History of a serious psychiatric disorder

  • Recent cancer diagnosis (<1 year)

  • Does not own a smartphone

Contacts and Locations

Locations

Site City State Country Postal Code
1 Weight Control and Diabetes Research Center Providence Rhode Island United States 02903

Sponsors and Collaborators

  • The Miriam Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Jessica Unick, PhD, The Miriam Hospital's Weight Control & Diabetes Research Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT03799289
Other Study ID Numbers:
  • 2096-18
  • R03DK115978-01A1
First Posted:
Jan 10, 2019
Last Update Posted:
Oct 28, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Miriam Hospital
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Period Title: Initial Weight Loss Program (Weeks 1-12)
STARTED 30 30
COMPLETED 24 27
NOT COMPLETED 6 3
Period Title: Initial Weight Loss Program (Weeks 1-12)
STARTED 24 27
COMPLETED 24 27
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Iyengar Yoga Cooking/Dietary Education Total
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention Total of all reporting groups
Overall Participants 24 27 51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
48.7
(9.9)
49.1
(9.5)
48.7
(9.6)
Sex: Female, Male (Count of Participants)
Female
24
100%
27
100%
51
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
16.7%
2
7.4%
6
11.8%
Not Hispanic or Latino
20
83.3%
25
92.6%
45
88.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
1
4.2%
0
0%
1
2%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
4.2%
1
3.7%
2
3.9%
White
19
79.2%
23
85.2%
42
82.4%
More than one race
3
12.5%
3
11.1%
6
11.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
24
100%
27
100%
51
100%
Body mass index (BMI) at baseline (pre weight loss) (kg /m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg /m^2]
34.6
(4.1)
34.5
(3.5)
34.6
(3.8)
Body mass index (BMI) at 12 weeks (post weight loss intervention) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
33.1
(4.5)
31.8
(3.7)
32.4
(4.1)

Outcome Measures

1. Primary Outcome
Title Program Satisfaction Ratings
Description Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
7.6
(2.9)
8.3
(2.4)
2. Primary Outcome
Title Intervention Session Attendance
Description Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [percentage of sessions attended]
75.4
(24.6)
75.9
(27.1)
3. Primary Outcome
Title Feasibility of the Intervention (Retention)
Description Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Count of Participants [Participants]
24
100%
27
100%
4. Secondary Outcome
Title Changes in Perceived Stress (Measured Via the Perceived Stress Scale)
Description Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
0.01
(0.51)
-0.06
(0.60)
5. Secondary Outcome
Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale
Description The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
1.7
(5.9)
0.9
(3.7)
6. Secondary Outcome
Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale
Description The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [Change on a scale]
-0.17
(5.1)
-0.9
(3.9)
7. Secondary Outcome
Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale
Description This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
-0.29
(3.06)
0.04
(5.03)
8. Secondary Outcome
Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale
Description This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [Change on a scale]
0.46
(4.34)
0.74
(4.59)
9. Secondary Outcome
Title Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale
Description This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
0.33
(3.17)
-1.67
(3.82)
10. Secondary Outcome
Title Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)
Description The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [units on a scale]
0.02
(0.51)
-0.06
(0.60)
11. Secondary Outcome
Title Change in Weight
Description Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.
Time Frame Change from 12 to 24 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Measure Participants 24 27
Mean (Standard Deviation) [Percent weight change]
-0.33
(2.91)
-0.38
(4.03)

Adverse Events

Time Frame 6 months
Adverse Event Reporting Description
Arm/Group Title Iyengar Yoga Cooking/Dietary Education
Arm/Group Description Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
All Cause Mortality
Iyengar Yoga Cooking/Dietary Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/24 (0%) 0/27 (0%)
Serious Adverse Events
Iyengar Yoga Cooking/Dietary Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/24 (0%) 0/27 (0%)
Other (Not Including Serious) Adverse Events
Iyengar Yoga Cooking/Dietary Education
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/24 (0%) 0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Jessica Unick, PD (Principal Investigator)
Organization The Miriam Hospital
Phone 401-793-8966
Email junick@lifespan.org
Responsible Party:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT03799289
Other Study ID Numbers:
  • 2096-18
  • R03DK115978-01A1
First Posted:
Jan 10, 2019
Last Update Posted:
Oct 28, 2021
Last Verified:
Jun 1, 2021