Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose (CTL)
31 de marzo de 2016 actualizado por: Charles B. Eaton, Memorial Hospital of Rhode Island
Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice
The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study.
It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort.
The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective.
The cost of intervention will be evaluated as it relates to study replication.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will translate and evaluate previously successful weight loss and physical activity studies into a primary care setting in terms of efficacy and cost effectiveness.
Patients are recruited by their primary care physicians office and screened for participation and contraindications by phone.
A screening visit with a run-in period of food and exercise log adherence is performed.
All participants have meetings with a Lifestyle Counselor to set nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6 months, and 12 months.
A structured eating plan will be given at the baseline visit.
Participants at the baseline visit are randomized to either the intervention and control groups.
During the first year, intervention participants will receive monthly motivational phone calls from their lifestyle counselor to assess their progress and help navigate the lifestyle changes.
Food and exercise logs are reviewed frequently and written feedback give to each interventional participant.
Intervention participants also receive weekly mailings focusing on weight loss, physical activity and healthy eating, and four tailored mailings based upon information gained through contact with the lifestyle counselor.
Intervention participants will also receive 2 informative DVDs during the first year.
Control participants receive 2 NIDDK informational handouts on weight loss.
For the second year of the study focuses on maintenance.
Intervention participants receive reduced mailings of 2 per month for 6 months and then once a month until the end of one year.
Intervention participants receive one additional motivational phone call at 13 months if they have not reached their weight loss goal and also receive 2 more informative DVDs.
The control participants will receive 3 informational NIDDK mailings.
The two arms of the study will be compared using the critical outcome measures (weight loss, PA, fat calories & vegetable/fruit servings consumed) and secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss efficacy.
We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss program in addition to the overall cost-effectiveness for the participant in terms of money spent and adverse events related to the lifestyle change.
Tipo de estudio
Intervencionista
Inscripción (Actual)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Rhode Island
-
Pawtucket, Rhode Island, Estados Unidos, 02816'
- Memorial Hospital of Rhode Island
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male/female ≥18 and <80 years old
- Available for this research project for the entire 24-month study period
- Able to read and speak English
- Can provide informed consent
Exclusion Criteria:
- Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
- Unstable psychiatric condition
- History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
- Limited physical activity by a physician to less than a brisk walk
- Another family member in the study
- Limited prescribed diet (e.g. gluten free diet)
- Present treatment for an eating disorder
- Underwent treatment for cancer in the past 5 years
- Dialysis
- Poorly controlled diabetes (HgbA1c > 10) or hospitalized in past 6 months for poorly controlled diabetes
- Chronic steroid therapy
- Participant requesting surgical treatment of obesity or weighing over 400 lbs.
- Major surgery in the past month
- Participating in another clinical trial with regards to obesity or physical activity
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months.
Maintenance mailings biweekly for six months and then monthly during the second year.
|
|
|
Comparador de placebos: Control
Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.
|
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Body Weight & Physical Activity
Periodo de tiempo: Five years
|
The primary outcomes of the trial are measured changes in BMI and physical activity level.
|
Five years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost Effectiveness
Periodo de tiempo: Five Years
|
Secondary outcomes are cost effectiveness of the intervention as measured by cost per unit of BMI loss.
Additional outcomes are changes in stages of change, decision balance, self-efficacy, and problem solving skills during the trial.
|
Five Years
|
|
Eating Behaviors
Periodo de tiempo: 5 years
|
Eating behaviors (measured as servings of fruits/vegtables and fat calories consumed) as self reported, Diet History Questionnaire II, SF-12, Eating Behavior Inventory, Three Factor Eating, and General Self Efficacy questionnaires
|
5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Charles B Eaton, MD, Memorial Hospital of Rhode Island
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2009
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de julio de 2015
Fechas de registro del estudio
Enviado por primera vez
27 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
1 de marzo de 2012
Publicado por primera vez (Estimar)
2 de marzo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
31 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 09-32
- 5R18DK079880 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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