Obesity
Conditions
Keywords
obesity, wellness, cardiovascular disease prevention, health at every size, weight loss
Brief summary
For over four decades the medical literature has observed a relationship between obesity and poorer health outcomes. The causal mechanisms of these poorer outcomes however are unclear. One assumption that has been supported by correlational data is that increased weight is associated with increased cardiovascular disease (CVD) risk factors (i.e., hypertension, dyslipidemia, and type 2 diabetes). Consequently, obese people are routinely prescribed weight loss programs in order to prevent or control these conditions. Unfortunately, long term weight loss has been met with minimal success for the large majority of people. Furthermore, the data suggesting that weight loss leads to long term health benefits and decreased mortality is limited and contradictory. The purpose of the proposed project is to perform a randomized controlled pilot study comparing the effectiveness of two lifestyle interventions for preventing CVD risk factors (hypertension, dyslipidemia, and type 2 diabetes). The interventions are constitutionally similar; however, the treatment condition is a wellness-focused intervention that teaches healthy living without consideration of weight. The control condition is a traditional curriculum where the prescribed outcome is weight loss. The primary goals of both programs are to reduce hypertension and total cholesterol, and to enhance glucose control. Secondary outcomes of interest are psychological and behavioral in nature (e.g., self-esteem; depressed mood; anxiety; stress; quality of life; dietary habits; and physical activity). We will compare the trajectories of the CVD and psychological/behavioral risk factors for a total period of 24 months (including the time from baseline to the end of the 6-month intervention). Our objectives are to collect data to a) determine whether participants in both programs reduce CVD and psychological/behavioral risk factors at the completion of the 6-month program, and b) compare the persistency of health improvements and rate of relapse at the end of the 18-month follow-up period between the traditional weight loss intervention and the wellness-focused intervention.
Interventions
BEHAVIORALWellness-Centered (HUGS)
A health at every size intervention, the HUGS program was conceived and developed in 1987 by Linda Omichinski, Registered Dietitian. HUGS stands for Health focused, Understanding lifestyle, Group supported, and Self-esteem building. It is an integrated approach that promotes healthy eating, active living, and self acceptance regardless of weight. HUGS teaches strategies to recognize and respond to physiological signs of hunger and satiety to determine food intake. The manualized curriculum is accompanied by the books Tailoring Your Tastes and Staying Off of the Diet Roller Coaster which participants will receive in addition to a booklet of handouts. Kelly Bliss, a psychotherapist and fitness professional with 17 years experience in health-centered approaches for weight management, will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
BEHAVIORALWeight-Centered (LEARN)
The LEARN Program for Weight Management is an evidence-based behavior modification approach to weight loss developed by Dr. Kelly Brownell, Ph.D. Psychologist. LEARN is an acronym that stands for Lifestyle, Exercise, Attitudes, Relationships, and Nutrition. This manualized curriculum shares many principals with the HUGS program in that both emphasize the importance of healthy lifestyle choices and gradual sustainable change. However, the LEARN program makes weight loss an explicit goal and focuses more on food intake levels based on external prescriptions and caloric restriction. Participants in the LEARN program will receive the LEARN Program for Weight Management manual and the LEARN Weight Stabilization and Maintenance Guide along with the LEARN Program CD set. Ann Wellock, a Registered Dietician from The Reading Hospital and Medical Center will deliver the intervention in 2 groups of 20 people that meet weekly for 6 months.
Sponsors
The Edna G. Kynett Memorial Foundation
The Reading Hospital and Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
There was full allocation concealment through the 3-month recruitment phase of the trial.
Intervention model description
1:1 Parallel assignment
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women ages 30 to 45 years old (at intervention onset); 2. BMI between 30 and 45 3. Physically inactive 4. Practicing birth control if heterosexually active and pre-menopausal. 5. English speaking
Exclusion criteria
1. Current smoker 2. Use of medications known to affect weight/energy expenditure; 3. Pregnant, intending to get pregnant over next two years, or lactating; 4. Recent myocardial infarction (within 6 months); 5. Congestive heart failure 6. Active neoplasms 7. Type 1 and insulin-dependent Type 2 diabetes 8. Cerebrovascular disease 9. Renal disease 10. Cirrhosis 11. Bulimia nervosa 12. Alcohol and/or Substance Abuse 13. Major psychiatric disturbance (suicidality, psychosis, anti-social personality disorder, current manic episode) 14. Prior bariatric surgery 15. Plans to have bariatric surgery over next 2.5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist-to-Hip ratio | Baseline, post-intervention, 18-24 months post intervention | waist in inches/hips in inches |
| Blood Lipids | Baseline, post-intervention, 18-24 months post intervention | LDL, HDL, Total Cholesterol, Triglycerides (mg/dL) |
| Blood Pressure | Baseline, post-intervention, 18-24 months post intervention | Systolic and Diastolic (mmHg) |
| Fasting Blood Glucose | Baseline, post-intervention, 18-24 months post intervention | measured in mg/DL |
| Waist and Hip Circumference | Baseline, post-intervention, 18-24 months post intervention | measured in inches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | baseline, post intervention, 18-24 months post intervention | Assessed with the question: I participate in moderately vigorous physical activity for about 30 minutes on average most days of the week. from the Red Lotus Health and Well-being Questionnaire, Range 0: (none of the time) to 5 (all of the time), higher scores indicate better outcome |
| Self-esteem | baseline, post intervention, 18-24 months post intervention | measured using the Rosenberg Self-esteem Scale, Range: 0-30, higher scores indicate a better outcome |
| Psychological distress | baseline, post intervention, 18-24 months post intervention | measured using the Depression Anxiety Stress Scale-21, Range: 0-168, higher scores indicate a worse outcome |
| Dietary habits | baseline, post intervention, 18-24 months post intervention | Assessment of foods most often consumed, measured using the Dietary Risk Assessment screener, Range 0-125, higher scores indicate higher worse outcome |
| Overall health and well-being status/Quality of life | baseline, post intervention, 18-24 months post intervention | measured using the Red Lotus Health and Well-being Questionnaire, Range: 15-75, higher scores indicate a better outcome |
| Disordered eating attitudes and behaviors | baseline, post intervention, 18-24 months post intervention | measured using the Eating Disorder Examination-Questionnaire (version 6), Range: 0-6, higher scores indicate worse outcome |
| Intuitive eating behaviors | baseline, post intervention, 18-24 months post intervention | Ability to engage in 'adaptive' eating (e.g., recognize internal signs of hunger and satiety) measured the Intuitive Eating Scale. Range: 1-5, higher scores indicate a better outcome |
| Maladaptive eating behaviors | baseline, post intervention, 18-24 months post intervention | Measured using the 'emotional eating' and 'uncontrolled eating' eating sub-scales of the Three-Factor Eating Questionnaire -Revised 18, Range: 0-100, higher scores indicate worse outcome |
| Fruit and vegetable intake | baseline, post intervention, 18-24 months post intervention | Assessed with the questions: I eat 2 or more servings of fruit/vegetables on average each day. from the Red Lotus Health and Well-being Questionnaire, Range 0: (none of the time) to 5 (all of the time), higher scores indicate better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Internalized weight stigma (putative mediator and moderator) | baseline, post intervention,18-24 months post intervention | Degree to which someone personally endorses and adopts negative attitudes about higher weight bodies for themselves. Measured using the Weight Bias Internalization Scale, Range: 1-7, higher scores indicate worse outcome |
Countries
United States
Outcome results
None listed