NCT06166225

Brief Summary

The purpose of this study is to examine whether the addition of online yoga classes, compared to health and wellness classes, can improve the amount of weight loss produced from an Internet-based weight loss program. All individuals will receive a 12-month, automated Internet-based weight loss program. Following 3 months of of weight loss treatment, individuals will be randomized to also receive yoga classes or health and wellness classes for 9 months. Assessments will occur at baseline, 3, 6, 12, and 18 months and will include measures of weight, eating behaviors, physical activity, and psychosocial factors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable obesity

Timeline
23mo left

Started Jan 2024

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2024Mar 2028

First Submitted

Initial submission to the registry

December 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

May 8, 2025

Status Verified

February 1, 2025

Enrollment Period

4.2 years

First QC Date

December 3, 2023

Last Update Submit

May 5, 2025

Conditions

Obesity

Keywords

yogaweight lossexercisediet

Outcome Measures

Primary Outcomes (1)

  • Percent weight change

    Weight change will be assessed via smart scales using weight at baseline and 12 months

    12 months

Secondary Outcomes (9)

  • Dietary lapses

    12 months

  • Affect

    12 months

  • Dietary temptations

    12 months

  • Percentage of time that tempting foods were eaten

    12 months

  • Dispositional mindfulness

    12 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • Percent weight change

    18 months

Study Arms (2)

Internet-based weight loss program + Iyengar yoga

EXPERIMENTAL

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month Iyengar yoga intervention (delivered during months 4-12). Yoga classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. They will also be asked to do self-guided yoga practice on their own and report their yoga practice on the study website.

Behavioral: Internet-based weight loss programBehavioral: Yoga

Internet-based weight loss program + health and wellness classes

ACTIVE COMPARATOR

Participants randomized to this group will receive a 12-month automated weight loss program which is delivered via the Internet and will also receive a 9-month health and wellness intervention (delivered during months 4-12). Health and wellness classes will be delivered live (via Zoom) and participants will be instructed to attend two classes per week for the first 14 weeks and one class per week thereafter. Classes will consist of lectures, videos, and discussions and will provide education around a variety of lifestyle topics.

Behavioral: Internet-based weight loss programBehavioral: Health and Wellness

Interventions

Internet-based weight loss programBEHAVIORAL

12-month, automated and behaviorally-based, Internet-delivered weight loss and weight loss maintenance program

Internet-based weight loss program + Iyengar yogaInternet-based weight loss program + health and wellness classes
YogaBEHAVIORAL

9-month Iyengar yoga program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12, and self-guided yoga practice recommendations.

Internet-based weight loss program + Iyengar yoga
Health and WellnessBEHAVIORAL

9-month health and wellness program consisting of live (Zoom) yoga classes delivered 1-2 times per week during months 4-12.

Internet-based weight loss program + health and wellness classes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI: 25-40 kg/m2
  • Must own smartphone and have daily, home Internet access

You may not qualify if:

  • Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months
  • Current or recent enrollment (\<2 years) in a weight loss program
  • Current or recent yoga, meditation, or mindfulness practice, either at home or in a studio (defined as ≥12 sessions within the past 2 years)
  • Presence of any medical condition for which yoga, exercise, weight loss, or dietary restriction is not recommended
  • Recent weight loss (≥10 pounds within the past 6 months)
  • Currently taking weight loss medications
  • History of bariatric surgery
  • Inability to walk 2 blocks without stopping
  • Baseline smartphone survey completion rate \<80%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Interventions

YogaHealth

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesPopulation Characteristics

Central Study Contacts

Jennifer Webster, BS

CONTACT

401-793-8946jwebster@lifespan.org

Jessica Unick, PhD

CONTACT

401-793-8966junick@lifespan.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2023

First Posted

December 12, 2023

Study Start

January 8, 2024

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

May 8, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Data will available to other researchers as raw individual-level data; however, this will not be available until the primary outcome papers from the study are accepted for publication. Requestors will be required to sign a data sharing agreement stating that: (1) They will use the data for research purposes only unless otherwise agreed, and will not identify any individual or personal information, (2) Data will be secured using appropriate technology/firewalls, (3) Data will be destroyed after data analysis, and (4) They will cite data appropriately in publications or other written materials. A record of transfer of data and a copy of the dataset that was distributed will be kept by The Miriam Hospital

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study data will be made available as soon as possible, but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication.

Locations

US(1)