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ObesitySHINENCT00960414

Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

A study testing SHINE in people with Obesity, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
SHINE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteUnited States
Study dates
Aug 2009to Aug 2013
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Osher Center for Integrative Medicine

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
SHINE
Keywords
obesity, randomized controlled trial, weight loss, metabolic syndrome
Medical subject headings
Obesity, Weight Loss, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHINEBehavioural

    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.

Study groups in NCT00960414
Study groupRoleWhat they receive
SHINE AExperimentalMindfulness training added to diet-exercise education.
Receives: Behavioral: SHINE
SHINE BActive comparatorDiet-exercise education.
Receives: Behavioral: SHINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight From Baseline to 18 Months

    weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data

    Measured: 18 months

Secondary outcomes (8)

  1. Fat Distribution

    change in waist circumference from baseline to 18 mos

    Measured: 0, 18 mo

  2. Insulin Sensitivity

    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.

    Measured: 18 mo

  3. Change in Perceived Stress From Baseline to 18 Months

    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).

    Measured: 18 mo

  4. Change in Positive Emotions Subscale of the Differential Emotions Scale

    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.

    Measured: 18 months

  5. Stress Hormones

    Measured: 0, 6, 12 mo

  6. Autonomic Nervous System Function

    Measured: 0, 3,6,12 months

  7. Adipocyte Activity

    Measured: 0, 6 mo

  8. Influenza Vaccine Response

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00960414
Sponsor's protocol ID
P01AT005013
Other IDs
P01AT005013
Acronym
SHINE
Status last verified
Jul 2024
First submitted
13 Aug 2009
Last updated
24 Jul 2024
Data monitoring committee
Yes

Publications

  • Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.

    PubMed 34544560

  • Daubenmier J, Chao MT, Hartogensis W, Liu R, Moran PJ, Acree MC, Kristeller J, Epel ES, Hecht FM. Exploratory Analysis of Racial/Ethnic and Educational Differences in a Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):503-514. doi: 10.1097/PSY.0000000000000859.

    PubMed 33214537

  • Radin RM, Epel ES, Daubenmier J, Moran P, Schleicher S, Kristeller J, Hecht FM, Mason AE. Do stress eating or compulsive eating influence metabolic health in a mindfulness-based weight loss intervention? Health Psychol. 2020 Feb;39(2):147-158. doi: 10.1037/hea0000807. Epub 2019 Nov 14.

    PubMed 31724424

  • Mason AE, Hecht FM, Daubenmier JJ, Sbarra DA, Lin J, Moran PJ, Schleicher SG, Acree M, Prather AA, Epel ES. Weight Loss Maintenance and Cellular Aging in the Supporting Health Through Nutrition and Exercise Study. Psychosom Med. 2018 Sep;80(7):609-619. doi: 10.1097/PSY.0000000000000616.

    PubMed 29901486

  • Hecht FM, Moskowitz JT, Moran P, Epel ES, Bacchetti P, Acree M, Kemeny ME, Mendes WB, Duncan LG, Weng H, Levy JA, Deeks SG, Folkman S. A randomized, controlled trial of mindfulness-based stress reduction in HIV infection. Brain Behav Immun. 2018 Oct;73:331-339. doi: 10.1016/j.bbi.2018.05.017. Epub 2018 May 26.

    PubMed 29842903

  • Daubenmier J, Moran PJ, Kristeller J, Acree M, Bacchetti P, Kemeny ME, Dallman M, Lustig RH, Grunfeld C, Nixon DF, Milush JM, Goldman V, Laraia B, Laugero KD, Woodhouse L, Epel ES, Hecht FM. Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial. Obesity (Silver Spring). 2016 Apr;24(4):794-804. doi: 10.1002/oby.21396. Epub 2016 Mar 9.

    PubMed 26955895

  • Mason AE, Epel ES, Aschbacher K, Lustig RH, Acree M, Kristeller J, Cohn M, Dallman M, Moran PJ, Bacchetti P, Laraia B, Hecht FM, Daubenmier J. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial. Appetite. 2016 May 1;100:86-93. doi: 10.1016/j.appet.2016.02.009. Epub 2016 Feb 8.

    PubMed 26867697

Questions about this trial

What is this clinical trial studying?

A study testing SHINE in people with Obesity, run by University of California, San Francisco 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 4 inclusion and 16 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 24 Jul 2024. 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 14 Feb 2024). 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?

Change in Weight From Baseline to 18 Months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960414, which also lists 7 linked publications.

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 24 Jul 2024.

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