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Text Messaging for Weight Loss

9 de noviembre de 2015 actualizado por: Kevin Hwang, MD, The University of Texas Health Science Center, Houston

Text Messaging for Weight Loss in Primary Care Patients

Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message.

The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.

Descripción general del estudio

Estado

Terminado

Condiciones

Obesidad

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

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

Estados Unidos
- Texas
  - Houston, Texas, Estados Unidos, 77030
    - UT Physicians - Internal Medicine

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP)
Age ≥ 21 years
Body mass index (BMI) 25 to 45 kg/m2 and weight ≤ 400 pounds
Goal of losing weight (not just maintain weight)
Willing to change diet, physical activity in order to lose weight.
Currently uses text messaging in English on mobile phone
Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided)
Have a scale at home for self-monitoring weight
Fluent in English (speak, read, write)
Commit to return for follow-up weight at 6 months regardless of amount of weight lost

Exclusion Criteria:

Involuntary or voluntary weight loss of ≥ 5% body weight in previous 6 months
Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months
Any of the following medical conditions which could affect weight or for which weight loss is contraindicated
- End-stage liver disease
- End-stage kidney disease
- Cancer within previous 2 years (except non-melanoma skin cancer)
Myocardial infarction, stroke, or transient ischemic attack within previous 6 months
Unstable angina
Severe arthritis or other medical conditions which would prevent brisk walking
Schizophrenia
Hospitalization for psychiatric problems during the prior 12 months.
Current use or anticipated future use (during 6 month study) of medications that could cause weight loss:
- phentermine
- orlistat (prescription Xenical or OTC Alli)
- topiramate
- buprioprion
- exenatide (Byetta)
- liraglutide (Victoza)
Prior bariatric surgery or plans for bariatric surgery in next 6 months
Pregnant or breast feeding within the previous 6 months
Planning to become pregnant in next 6 months
Consumes > 14 alcoholic drinks per week
Current use of illicit drugs
Planning to move out of the area in the next 6 months
Another member of household or a close contact is participating in the study

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Experimental: Personal feedback This arm will receive all intervention components of Active Comparator group, plus the following: Text messages to prompt participant to reply with self-monitoring entries Human coach uses system to send personalized text messages with feedback on self-monitoring entries	Conductual: Personal feedback
Comparador activo: One Way Text Printed handouts from the "Aim for a Healthy Weight" booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies. Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss. One to three text messages per week, based on topics from "Aim for a Healthy Weight" and other sources. The text messages will be pre-scheduled, automated, non-tailored, and "one-way" (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting. Usual medical care from the PCP. Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms.	Conductual: one way text

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Personal feedback

This arm will receive all intervention components of Active Comparator group, plus the following:

Text messages to prompt participant to reply with self-monitoring entries
Human coach uses system to send personalized text messages with feedback on self-monitoring entries

Conductual: Personal feedback

Comparador activo: One Way Text

Printed handouts from the "Aim for a Healthy Weight" booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies.
Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss.
One to three text messages per week, based on topics from "Aim for a Healthy Weight" and other sources. The text messages will be pre-scheduled, automated, non-tailored, and "one-way" (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting.
Usual medical care from the PCP.
Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms.

Conductual: one way text

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change in weight from baseline Periodo de tiempo: baseline and 6 months	Weight in a lightweight hospital gown with no shoes (calibrated digital scale)	baseline and 6 months

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change in diet measured by Fruit and Vegetable Screener (NCI) Periodo de tiempo: baseline and 6 months		baseline and 6 months
Change in physical activity as measured by Paffenbarger physical activity questionnaire Periodo de tiempo: baseline and 6 months		baseline and 6 months
Change in social support as measured by Weight Management Support Inventory Periodo de tiempo: baseline and 6 months	A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)	baseline and 6 months
Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Periodo de tiempo: baseline and 6 months	Measures the individual's self-rated executive functioning.	baseline and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The University of Texas Health Science Center, Houston

Investigadores

Investigador principal: Kevin O. Hwang, MD, The University of Texas Health Science Center, Houston

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 octubre de 2012

Finalización primaria (Actual)

1 de marzo de 2015

Finalización del estudio (Actual)

1 de marzo de 2015

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

21 de noviembre de 2012

Publicado por primera vez (Estimar)

29 de noviembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de noviembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

HSC-MS-12-0571

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Text Messaging for Weight Loss