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ObesityNCT00769717

Evaluation of a Health at Every Size vs a Behavioral Weight Loss Approach for Obese Women

A study testing Wellness-Centered (HUGS) and Weight-Centered (LEARN) in people with Obesity, run by The Reading Hospital and Medical Center 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

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. Read more about this study

Who is it for?
Ages 30 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Wellness-Centered (HUGS) and Weight-Centered (LEARN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
25 Sep 2008to 25 Feb 2011
Phase
Interventional
Are there results?
None posted in the registry

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 30 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women ages 30 to 45 years old (at intervention onset);
  • BMI between 30 and 45
  • Physically inactive
  • Practicing birth control if heterosexually active and pre-menopausal.
  • English speaking

Who cannot join

  • Current smoker
  • Use of medications known to affect weight/energy expenditure;
  • Pregnant, intending to get pregnant over next two years, or lactating;
  • Recent myocardial infarction (within 6 months);
  • Congestive heart failure
  • Active neoplasms
Show all 15Show fewer
  • Type 1 and insulin-dependent Type 2 diabetes
  • Cerebrovascular disease
  • Renal disease
  • Cirrhosis
  • Bulimia nervosa
  • Alcohol and/or Substance Abuse
  • Major psychiatric disturbance (suicidality, psychosis, anti-social personality disorder, current manic episode)
  • Prior bariatric surgery
  • Plans to have bariatric surgery over next 2.5 years

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

Other trials in United States

About this study

Official title: Comparative Health Improvements and Rate of Relapse in Weight-Centered vs. Wellness-Centered Interventions for Obese Women

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.

Conditions
Obesity
Being tested
Wellness-Centered (HUGS), Weight-Centered (LEARN)
Keywords
obesity, wellness, cardiovascular disease prevention, health at every size, weight loss
Medical subject headings
Obesity, Weight Loss

What participants receive

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

  • Wellness-Centered (HUGS)Behavioural

    Also called Health At Every Size, Intuitive Eating

    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.

  • Weight-Centered (LEARN)Behavioural

    Also called behavior based weight loss program

    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.

Study groups in NCT00769717
Study groupRoleWhat they receive
Wellness-CenteredExperimentalA 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.
Receives: Behavioral: Wellness-Centered (HUGS)
Weight-CenteredActive comparatorThe 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.
Receives: Behavioral: Weight-Centered (LEARN)

What is being measured

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

  1. Blood Lipids

    LDL, HDL, Total Cholesterol, Triglycerides (mg/dL)

    Measured: Baseline, post-intervention, 18-24 months post intervention

  2. Blood Pressure

    Systolic and Diastolic (mmHg)

    Measured: Baseline, post-intervention, 18-24 months post intervention

  3. Fasting Blood Glucose

    measured in mg/DL

    Measured: Baseline, post-intervention, 18-24 months post intervention

  4. Waist and Hip Circumference

    measured in inches

    Measured: Baseline, post-intervention, 18-24 months post intervention

  5. Waist-to-Hip ratio

    waist in inches/hips in inches

    Measured: Baseline, post-intervention, 18-24 months post intervention

Secondary outcomes (9)
  1. Disordered eating attitudes and behaviors

    measured using the Eating Disorder Examination-Questionnaire (version 6), Range: 0-6, higher scores indicate worse outcome

    Measured: baseline, post intervention, 18-24 months post intervention

  2. Intuitive eating behaviors

    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

    Measured: baseline, post intervention, 18-24 months post intervention

  3. Maladaptive eating behaviors

    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

    Measured: baseline, post intervention, 18-24 months post intervention

  4. Fruit and vegetable intake

    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

    Measured: baseline, post intervention, 18-24 months post intervention

  5. Physical activity

    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

    Measured: baseline, post intervention, 18-24 months post intervention

  6. Self-esteem

    measured using the Rosenberg Self-esteem Scale, Range: 0-30, higher scores indicate a better outcome

    Measured: baseline, post intervention, 18-24 months post intervention

  7. Overall health and well-being status/Quality of life

    measured using the Red Lotus Health and Well-being Questionnaire, Range: 15-75, higher scores indicate a better outcome

    Measured: baseline, post intervention, 18-24 months post intervention

  8. Psychological distress

    measured using the Depression Anxiety Stress Scale-21, Range: 0-168, higher scores indicate a worse outcome

    Measured: baseline, post intervention, 18-24 months post intervention

  9. Dietary habits

    Assessment of foods most often consumed, measured using the Dietary Risk Assessment screener, Range 0-125, higher scores indicate higher worse outcome

    Measured: baseline, post intervention, 18-24 months post intervention

Timeline

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

  1. First posted9 Oct 2008 (estimated)
  2. Study start25 Sep 2008
  3. Primary completion25 Feb 2011
  4. Study completion25 Feb 2011

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
Model description
1:1 Parallel assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769717
Sponsor's protocol ID
TRHMC 02708
Status last verified
Nov 2019
First submitted
8 Oct 2008
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No

Publications

  • Mensinger JL, Calogero RM, Stranges S, Tylka TL. A weight-neutral versus weight-loss approach for health promotion in women with high BMI: A randomized-controlled trial. Appetite. 2016 Oct 1;105:364-74. doi: 10.1016/j.appet.2016.06.006. Epub 2016 Jun 8.

    PubMed 27289009
  • Mensinger JL, Calogero RM, Tylka TL. Internalized weight stigma moderates eating behavior outcomes in women with high BMI participating in a healthy living program. Appetite. 2016 Jul 1;102:32-43. doi: 10.1016/j.appet.2016.01.033. Epub 2016 Jan 29.

    PubMed 26829370
  • Mensinger, J. L., & Meadows, A. (2017). Internalized weight stigma mediates and moderates physical activity outcomes during a healthy living program for women with high body mass index. Psychology of Sport and Exercise, 30, 64-72. doi:10.1016/j.psychsport.2017.01.010

Questions about this trial

What is this clinical trial studying?

A study testing Wellness-Centered (HUGS) and Weight-Centered (LEARN) in people with Obesity, run by The Reading Hospital and Medical Center 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 5 inclusion and 15 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 3 Dec 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Blood Lipids (time frame: Baseline, post-intervention, 18-24 months post intervention). The study lists 5 primary outcomes in all. 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 NCT00769717, which also lists 3 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 3 Dec 2019.

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