ObesityNCT03799289
Approaches for Improving Long-term Weight Loss
A study testing Behavioral weight loss followed by yoga instruction and Behavioral weight loss followed by cooking/dietary education instruction in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral weight loss followed by yoga instruction and Behavioral weight loss followed by cooking/dietary education instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-40 kg/m2
- Female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Behavioral weight loss followed by yoga instruction, Behavioral weight loss followed by cooking/dietary education instruction
- Keywords
- Obesity, Weight loss, physical activity, yoga, exercise
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight loss followed by yoga instructionBehavioural
12-week standard behavioral weight loss program followed by a 12-week yoga intervention
Behavioral weight loss followed by cooking/dietary education instructionBehavioural
12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
| Study group | Role | What they receive |
|---|---|---|
| Iyengar Yoga | Experimental | 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. Receives: Behavioral: Behavioral weight loss followed by yoga instruction |
| Cooking/dietary education | Active comparator | 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. Receives: Behavioral: Behavioral weight loss followed by cooking/dietary education instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Intervention Session Attendance
Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (8)
Changes in Perceived Stress (Measured Via the Perceived Stress Scale)
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.
Measured: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale
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.
Measured: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale
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.
Measured: Change from 12 to 24 weeks
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.
Measured: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale
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.
Measured: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale
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.
Measured: Change from 12 to 24 weeks
Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)
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.
Measured: Change from 12 to 24 weeks
Change in Weight
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.
Measured: Change from 12 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start3 Jan 2019
- Primary completion18 Jun 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Unick, PhD, Principal investigator, The Miriam Hospital's Weight Control & Diabetes Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799289
- Sponsor's protocol ID
- 2096-18
- Other IDs
- R03DK115978-01A1
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2018
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss
- ClinicalTrials.gov ID
- NCT03799289
- Acronym / sponsor ID
- 2096-18
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, physical activity, yoga, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iyengar Yoga | Experimental | Behavioral: Behavioral weight loss followed by yoga instructionParticipants 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. |
| Cooking/dietary education | Active comparator | Behavioral: Behavioral weight loss followed by cooking/dietary education instructionParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 25-40 kg/m2
- Female
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral weight loss followed by yoga instruction12-week standard behavioral weight loss program followed by a 12-week yoga intervention | Behavioural | Iyengar Yoga |
| Behavioral weight loss followed by cooking/dietary education instruction12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention | Behavioural | Cooking/dietary education |
Primary outcome
Program Satisfaction Ratings
Time frame: 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
Time frame: 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)
Time frame: 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
8 secondary outcomes
Changes in Perceived Stress (Measured Via the Perceived Stress Scale)
Time frame: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale
Time frame: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale
Time frame: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale
Time frame: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale
Time frame: Change from 12 to 24 weeks
Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale
Time frame: Change from 12 to 24 weeks
Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)
Time frame: Change from 12 to 24 weeks
Change in Weight
Time frame: Change from 12 to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Unick, PhD principal investigator
The Miriam Hospital's Weight Control & Diabetes Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral weight loss followed by yoga instruction and Behavioral weight loss followed by cooking/dietary education instruction in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Satisfaction Ratings (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.