Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons (SHINE)

July 2, 2024 updated by: University of California, San Francisco

Supporting Health by Integrating Nutrition and Exercise (SHINE)

The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The high prevalence of obesity and its medical consequences make it one of the most important public health issues in the United States today. Few interventions have been consistently successful at reducing obesity. This trial will test an intervention program that lasts 22 weeks, with 16 evening sessions and one weekend day. Participants will be randomized to one of two arms. Both arms will receive diet and exercise intervention elements. The study aims for gradual weight loss, with a calorie target that will maintain ideal body weight, rather than a more calorie restricted diet. The exercise component is based around increasing walking. The arms will compare methods for producing long-lasting behavior change.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Osher Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18+ years old
  • BMI > 30-45
  • Waist circumference > 102 cm (men) or > 88 cm (women)
  • Live in San Francisco Bay Area and able to attend more than 16 classes and up to 12 assessment visits in San Francisco over an 18 month period

Exclusion Criteria:

  • Inability to provide informed consent
  • Age < 18
  • A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the group intervention
  • Type I or II Diabetes or fasting glucose ≥ 126 mg/dl or hemoglobin A1c ≥ 6.5; those with HbA1c between 6-6.5% may complete an OGTT to rule out diabetes (glucose <200 mg/dl)
  • Use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications
  • Use of immunosuppressive or immunomodulating drugs or chronic or acute conditions that would require the use of such medications
  • A history of known coronary artery disease (CAD), or typical or atypical anginal chest pain requires a letter from the participant's physician that he or she has been adequately evaluated and that a moderate exercise program is appropriate
  • Non English speaker
  • Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum
  • Initiation of new class of psychiatric medications in past 2 months
  • Currently on a specific weight loss diet
  • For influenza vaccine administration: a prior allergic reaction to the influenza vaccine or eggs. These participants can be included in the trial but will be excluded from participation in influenza vaccination.
  • Active bulimia or strong history of bulimia
  • Current use of weight loss medications or supplements such as amphetamine-based drugs that are believed to have some effect on weight
  • History of or planned weight loss surgery
  • Untreated hypothyroidism: TSH > 4mU/mL (or the upper limit of normal reference defined by the lab doing the assay)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHINE A
Mindfulness training added to diet-exercise education.
Behavioral: SHINE
Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detailed nutritional education.
Active Comparator: SHINE B
Diet-exercise education.
Behavioral: SHINE
Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detailed nutritional education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight From Baseline to 18 Months
Time Frame: 18 months
weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat Distribution
Time Frame: 0, 18 mo
change in waist circumference from baseline to 18 mos
0, 18 mo
Insulin Sensitivity
Time Frame: 18 mo
change in HOMA from baseline to 18 months. HOMA-IR is a validated assessment of insulin resistance. HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
18 mo
Change in Perceived Stress From Baseline to 18 Months
Time Frame: 18 mo
Change in Perceived Stress Scale scores from baseline to 18 months (i.e. approximately one year post-intervention completion), using intention-to-treat. Scores range from 0-40, with higher scores indicating higher perceived stress (worse outcome).
18 mo
Stress Hormones
Time Frame: 0, 6, 12 mo
0, 6, 12 mo
Autonomic Nervous System Function
Time Frame: 0, 3,6,12 months
0, 3,6,12 months
Adipocyte Activity
Time Frame: 0, 6 mo
0, 6 mo
Influenza Vaccine Response
Time Frame: 3 months
3 months
Change in Positive Emotions Subscale of the Differential Emotions Scale
Time Frame: 18 months

We used the 10-item positive emotions subscale of the Differential Emotions Scale (DES; Izard et al., 1991) to assess the extent to which a participant experienced positive emotions in the prior week. Participants responded on a five-point scale (0 = not at all, 4

= extremely; total score possible range 0-40). We summed items to create a total score, with higher scores indicating more positive emotions.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Frederick Hecht, MD, University of California, San Francisco
  • Study Chair: Elissa Epel, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimated)

August 17, 2009

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01AT005013 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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