Obesity
Conditions
Keywords
obesity, randomized controlled trial, weight loss, metabolic syndrome
Brief summary
The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.
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.
Interventions
BEHAVIORALSHINE
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight From Baseline to 18 Months | 18 months | weight loss at 18 month visit, approximately one year post-intervention completion, using attention-to-treat analyses of observed data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity | 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. |
| Change in Perceived Stress From Baseline to 18 Months | 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). |
| Change in Positive Emotions Subscale of the Differential Emotions Scale | 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. |
| Fat Distribution | 0, 18 mo | change in waist circumference from baseline to 18 mos |
| Autonomic Nervous System Function | 0, 3,6,12 months | — |
| Adipocyte Activity | 0, 6 mo | — |
| Influenza Vaccine Response | 3 months | — |
| Stress Hormones | 0, 6, 12 mo | — |
Countries
United States
Participant flow
Recruitment details
We recruited participants for a weight loss study comparing two programs involving diet, exercise, and stress management from the community using fliers, newspaper advertisements, online postings, and referrals at UCSF clinics. Participants were enrolled in 6 rounds from July 2009-February 2012. Assessments were completed in October 2013.
Participants by arm
| Arm | Count |
|---|---|
| SHINE A 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 detained nutritional education. | 100 |
| SHINE B 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 detained nutritional education. | 94 |
| Total | 194 |
Baseline characteristics
| Characteristic | SHINE A | SHINE B | Total |
|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 13 | 46.8 years STANDARD_DEVIATION 12.4 | 47.0 years STANDARD_DEVIATION 12.7 |
| Body Mass Index | 35.4 kg/m^2 STANDARD_DEVIATION 3.5 | 35.6 kg/m^2 STANDARD_DEVIATION 3.8 | 35.47 kg/m^2 STANDARD_DEVIATION 3.6 |
| Education | 69 participants with bachelor's degree | 56 participants with bachelor's degree | 125 participants with bachelor's degree |
| Race/Ethnicity, Customized African American | 13 participants | 12 participants | 25 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 8 participants | 11 participants | 19 participants |
| Race/Ethnicity, Customized Latina/Latino | 7 participants | 16 participants | 23 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other | 7 participants | 3 participants | 10 participants |
| Race/Ethnicity, Customized White | 65 participants | 50 participants | 115 participants |
| Sex: Female, Male Female | 79 Participants | 81 Participants | 160 Participants |
| Sex: Female, Male Male | 21 Participants | 13 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 94 |
| other Total, other adverse events | 0 / 100 | 0 / 94 |
| serious Total, serious adverse events | 0 / 100 | 0 / 94 |
Outcome results
Primary
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
Time frame: 18 months
Population: Two women in Arm B had weight-related variables censored at 18 months due to pregnancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHINE A | Change in Weight From Baseline to 18 Months | -5.0 kg | Standard Deviation 0.9 |
| SHINE B | Change in Weight From Baseline to 18 Months | -3.2 kg | Standard Deviation 1 |
Secondary
Adipocyte Activity
Time frame: 0, 6 mo
Secondary
Autonomic Nervous System Function
Time frame: 0, 3,6,12 months
Secondary
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).
Time frame: 18 mo
Population: 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHINE A | Change in Perceived Stress From Baseline to 18 Months | -1.03 units on a scale | Standard Error 0.57 |
| SHINE B | Change in Perceived Stress From Baseline to 18 Months | -0.11 units on a scale | Standard Error 0.61 |
Secondary
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.
Time frame: 18 months
Population: 8 participants in Arm A and 3 in Arm B did not complete this self-report survey at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHINE A | Change in Positive Emotions Subscale of the Differential Emotions Scale | 2.49 score on a scale | Standard Error 0.67 |
| SHINE B | Change in Positive Emotions Subscale of the Differential Emotions Scale | -0.21 score on a scale | Standard Error 0.7 |
Secondary
Fat Distribution
change in waist circumference from baseline to 18 mos
Time frame: 0, 18 mo
Population: Two women in Arm B had weight-related variables censored at 18 months due to pregnancy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHINE A | Fat Distribution | -4.8 cm | Standard Deviation 0.9 |
| SHINE B | Fat Distribution | -3.6 cm | Standard Deviation 1 |
Secondary
Influenza Vaccine Response
Time frame: 3 months
Secondary
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.
Time frame: 18 mo
Population: 2 participants in Arm A and 1 participant in Arm B did not have the lab results needed to calculate HOMA-IR at 18 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHINE A | Insulin Sensitivity | -.011 units on a scale | Standard Error 0.23 |
| SHINE B | Insulin Sensitivity | 0.50 units on a scale | Standard Error 0.25 |
Secondary
Stress Hormones
Time frame: 0, 6, 12 mo