Trial Outcomes & Findings for Approaches for Improving Long-term Weight Loss (NCT NCT03799289)

NCT ID: NCT03799289

Last Updated: 2021-10-28

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-10-28

Participant Flow

Participant milestones

Measure	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 weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention	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 weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
Initial Weight Loss Program (Weeks 1-12) STARTED	30	30
Initial Weight Loss Program (Weeks 1-12) COMPLETED	24	27
Initial Weight Loss Program (Weeks 1-12) NOT COMPLETED	6	3
Maintenance Intervention (Weeks 13-24) STARTED	24	27
Maintenance Intervention (Weeks 13-24) COMPLETED	24	27
Maintenance Intervention (Weeks 13-24) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Approaches for Improving Long-term Weight Loss

Baseline characteristics by cohort

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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 n=51 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 9.9 • n=5 Participants	49.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	48.7 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	27 participants n=7 Participants	51 participants n=5 Participants
Body mass index (BMI) at baseline (pre weight loss)	34.6 kg /m^2 STANDARD_DEVIATION 4.1 • n=5 Participants	34.5 kg /m^2 STANDARD_DEVIATION 3.5 • n=7 Participants	34.6 kg /m^2 STANDARD_DEVIATION 3.8 • n=5 Participants
Body mass index (BMI) at 12 weeks (post weight loss intervention)	33.1 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants	31.8 kg/m^2 STANDARD_DEVIATION 3.7 • n=7 Participants	32.4 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Program Satisfaction Ratings	7.6 units on a scale Standard Deviation 2.9	8.3 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Intervention Session Attendance	75.4 percentage of sessions attended Standard Deviation 24.6	75.9 percentage of sessions attended Standard Deviation 27.1

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Feasibility of the Intervention (Retention)	24 Participants	27 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Changes in Perceived Stress (Measured Via the Perceived Stress Scale)	0.01 units on a scale Standard Deviation 0.51	-0.06 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale	1.7 units on a scale Standard Deviation 5.9	0.9 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale	-0.17 Change on a scale Standard Deviation 5.1	-0.9 Change on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale	-0.29 units on a scale Standard Deviation 3.06	0.04 units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale	0.46 Change on a scale Standard Deviation 4.34	0.74 Change on a scale Standard Deviation 4.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale	0.33 units on a scale Standard Deviation 3.17	-1.67 units on a scale Standard Deviation 3.82

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)	0.02 units on a scale Standard Deviation 0.51	-0.06 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Iyengar Yoga n=24 Participants 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	Cooking/Dietary Education n=27 Participants 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
Change in Weight	-0.33 Percent weight change Standard Deviation 2.91	-0.38 Percent weight change Standard Deviation 4.03

Adverse Events

Iyengar Yoga

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cooking/Dietary Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Unick, PD (Principal Investigator)

The Miriam Hospital

Phone: 401-793-8966

Email: junick@lifespan.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place