Metabolic Syndrome
Conditions
Keywords
weight loss, metabolic syndrome, stress, obesity
Brief summary
The purpose of this study is to learn the impact stress may have on weight management and emotional eating.
Detailed description
The investigator's long-term goal is to contribute to the development of empirically-based, clinically-useful weight loss and weight maintenance interventions. The objective in this application is to obtain proof of feasibility for a weight loss and maintenance intervention that addresses the underlying issue of stress, as an effective approach to long-term weight loss and maintenance. The central hypothesis for this application is that the weight management intervention utilizing stress management skills will produce weight loss and significant improvements in stress and metabolic syndrome biomarkers at 10 and 20 weeks follow-up. This hypothesis was formulated based upon data showing that stress is associated with increased risk of obesity and a few small studies that have shown this method of stress management can produce long-term weight loss and maintenance and decreased depression and stress. The rationale for the proposed studies is that proof of feasibility for such an intervention will enable subsequent definitive studies at the R01 level. If, however, the investigators were to unexpectedly disprove the concept, such a result would also be valuable because it would lead the investigators to shift focus and redistribute resources accordingly. To test the central hypothesis, and thereby accomplish the objective for this application, the following specific aims will be pursued: 1. Compare a stress management based program to a standard behavioral weight loss program for weight loss and cost-effectiveness. The approach will involve two different intervention groups. Group 1(control) will receive a standard behavioral weight loss program. Group 2 will receive a stress management based intervention built on research in neuroscience and principles of the attachment theory. 2. Determine secondary outcomes from both interventions, including stress as measured by the perceived stress scale. It is hypothesized that Group 2 will show greater improvements in stress at both 10 and 20 weeks follow-up than Group 1. At the completion of this study, the investigators expect to determine the type of intervention that produces the greatest weight loss in a community sample at 10 and 20 weeks follow-up. The investigators will also have determined what impact the two interventions have on secondary outcomes, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity.
Interventions
BEHAVIORALEmotional brain training
Stress management based program
BEHAVIORALBehavioral weight loss
Standard behavioral weight loss
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Kelly Webber
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* be 25-55 years of age * have a BMI of \> 28 and \<45 * meet criteria for at least one additional risk factor for metabolic syndrome (Participants will be screened for waist circumference and blood pressure to ensure inclusion in the study.) * own and use a smart phone.
Exclusion criteria
* have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise * endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells * endorse any of the other items on the PAR-Q without a physician's consent * have had a hospitalization for a psychiatric disorder within the last year * have a history of anorexia or bulimia nervosa * have a medical diagnosis of cancer or HIV * have a diagnosis of a major psychiatric disorder (i.e. bipolar disorder or schizophrenia) or taking anti-psychotic medications * be pregnant, nursing, or planning to become pregnant within the study period * be less than 9 months post-partum * have a weight loss of \> 10 pounds in the last six months * be on more than two medications for hypertension control * greater than stage 3 kidney disease * be taking insulin to control diabetes * be taking Coumadin * be taking Lasix * anyone, who in the opinion of the study investigators, would not be a good candidate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | Weight change from baseline to 20 weeks | Weight change from baseline to 20 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Stress | PSS change from baseline to 20 weeks | Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stress Management Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program | 24 |
| Standard Behavioral Weight Loss Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Total | Stress Management | Standard Behavioral Weight Loss |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 24 Participants | 25 Participants |
| Age, Continuous | 45.0 years STANDARD_DEVIATION 7.9 | 45.5 years STANDARD_DEVIATION 8 | 44.0 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 49 participants | 24 participants | 25 participants |
| Sex: Female, Male Female | 41 Participants | 20 Participants | 21 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
Weight Loss
Weight change from baseline to 20 weeks
Time frame: Weight change from baseline to 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stress Management | Weight Loss | 1.6 kg | Standard Deviation 3.8 |
| Standard Behavioral Weight Loss | Weight Loss | 3.9 kg | Standard Deviation 3.3 |
Secondary
Decrease in Stress
Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.
Time frame: PSS change from baseline to 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stress Management | Decrease in Stress | -4.5 units on a scale |
| Standard Behavioral Weight Loss | Decrease in Stress | -1.8 units on a scale |