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Active, Not Recruiting

NCT Number: NCT06166225

Strategies for Improving Remote-based Weight Loss (PATH Trial)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

All individuals enrolled in this study will receive a 12-month Internet-based weight loss program, consisting of a 3-month weight loss program, followed by a 9-month weight loss maintenance program. Each week during the first 3 months individuals will be asked to view a 10 to 15-minute multi-media lesson. These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 3-month weight loss program participants will receive a 9-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful weight loss maintenance and be instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website. Automated, monthly feedback is provided.

In addition, participants completing the 3-month weight loss program will be randomly assigned to receive either 9 months of Iyengar yoga classes or 9 months of health and wellness classes. These classes will be held twice per week (live via Zoom) for 14 weeks and then once per week thereafter.

To evaluate the program, participants are asked to complete assessments prior to starting the program (baseline) and at 3, 6, 12 (post-treatment), and 18 months (6 months after completion of the program). For these assessments, participants will be asked to weigh themselves on their study scale, complete a series of online surveys, wear a physical activity monitor for 10 days, and answer daily surveys on their smartphone for 10 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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%

Treatment and study plan

Internet-based weight loss program

Behavioral

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

Yoga

Behavioral

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.

Health and Wellness

Behavioral

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

Primary outcomes

  1. Percent weight change

    Time frame: 12 months

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

Secondary outcomes

  1. Dietary lapses

    Time frame: 12 months

    Dietary lapses will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about any dietary lapses since completing the last survey.

  2. Affect

    Time frame: 12 months

    Affect will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about current affect.

  3. Dietary temptations

    Time frame: 12 months

    Dietary temptations will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about dietary temptations experienced since the last prompt.

  4. Percentage of time that tempting foods were eaten

    Time frame: 12 months

    Dietary temptations will be assessed via ecological momentary assessment (EMA). Participants receive EMA surveys 5x/day, for 10 days, at baseline and 12 months, and surveys ask about dietary temptations experienced since the last prompt. If a temptation is reported, participants are asked to state whether they ate the tempting food. The percentage of time that tempting foods were eaten (vs. not eaten) will be calculated.

  5. Dispositional mindfulness

    Time frame: 12 months

    Mindfulness will be assessed via the Five Facet Mindfulness Questionnaire - Short Form at baseline and 12 months

  6. Distress tolerance

    Time frame: 12 months

    Distress tolerance will be assessed via the Distress Tolerance Scale at baseline and 12 months

  7. Self-compassion

    Time frame: 12 months

    Self-compassion will be assessed via the Self-Compassion Scale - Short Form at baseline and 12 months

  8. Behavioral inhibition

    Time frame: 12 months

    Behavioral inhibition will be assessed via the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Questionnaire at baseline and 12 months and the BIS subscale will be assessed.

  9. Self-efficacy

    Time frame: 12 months

    Self-efficacy will be assessed using the Weight Efficacy Lifestyle Questionnaire at baseline and 12 months.

Other outcomes

  1. Percent weight change

    Time frame: 18 months

    Weight change will be assessed via smart scales using weight at baseline and 18 months to examine the long-term effects of the interventions.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Remote-based Yoga Intervention for Improving Long-term Weight Loss

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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