Approaches for Improving Long-term Weight Loss

Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03799289

Enrollment

Registered

2019-01-10

Start date

2019-01-03

Completion date

2020-12-29

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Weight loss, physical activity, yoga, exercise

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.

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.

Interventions

BEHAVIORALBehavioral weight loss followed by yoga instruction

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

BEHAVIORALBehavioral weight loss followed by cooking/dietary education instruction

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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)
Intervention Session Attendance	6 months	Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	24
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	27
Total	51

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 24	0 / 27
other Total, other adverse events	0 / 24	0 / 27
serious Total, serious adverse events	0 / 24	0 / 27

Outcome results

Primary

Feasibility of the Intervention (Retention)

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Iyengar Yoga	Feasibility of the Intervention (Retention)	24 Participants
Cooking/Dietary Education	Feasibility of the Intervention (Retention)	27 Participants

Primary

Intervention Session Attendance

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

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Iyengar Yoga	Intervention Session Attendance	75.4 percentage of sessions attended	Standard Deviation 24.6
Cooking/Dietary Education	Intervention Session Attendance	75.9 percentage of sessions attended	Standard Deviation 27.1

Primary

Program Satisfaction Ratings

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

Arm	Measure	Value (MEAN)	Dispersion
Iyengar Yoga	Program Satisfaction Ratings	7.6 units on a scale	Standard Deviation 2.9
Cooking/Dietary Education	Program Satisfaction Ratings	8.3 units on a scale	Standard Deviation 2.4

Secondary

Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale

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.