Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Evitar y resistir estrategias para controlar el peso

15 de octubre de 2026 actualizado por: Sarah Salvy, Cedars-Sinai Medical Center

Evaluación de las estrategias de control ambiental (EVITAR) y control inhibitorio (RESIST) para mejorar los resultados del control del peso

The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST).

Descripción general del estudio

Descripción detallada

Evidence-based weight management programs are effective when individuals are able to consistently adhere to recommendations. However, a large proportion of treatment-seeking individuals do not experience clinically significant weight loss. Innovative strategies are needed to optimize behavior change in weight management interventions. The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST). Specifically, 500 women and men (BMI between 25-45 kg/m2) will be recruited from the Cedars-Sinai Medical Center network of hospitals and clinics. All participants will be enrolled in a 12-month weight-management program (WW, formerly Weight Watchers©) focusing on diet, physical activity and mindset skills, and randomized to one of four study arms: (1) WW only, (2) WW + modification of home food environment and online grocery delivery (AVOID), (3) WW + gamified inhibitory control training (RESIST), (4) WW + AVOID + RESIST. Baseline, 6- and 12-month assessments will be completed by experienced, English and Spanish speaking study staff. Aim 1 (Outcomes). (a) Tests how AVOID and RESIST affect weight loss and waist circumference (primary) and diet quality (secondary). H1a: AVOID and/or RESIST (arms 2, 3, 4) will result in greater weight loss at 6-month and 12-month timepoints compared to WW alone. (b) Tests potential ripple effects of AVOID and RESIST on available household members' diet quality (primary) and weight (secondary). H1b: The investigators predict that AVOID (arms 2 and 4) will produce greater dietary changes in household members than WW alone and RESIST (arms 1 and 3). Aim 2 (Mechanisms). Tests the mechanistic pathways of AVOID and RESIST by (a) comparing longitudinal changes in inhibitory control and home food environment across study arms; and (b) whether inhibitory control and the home food environment mediate the relationships between study arms and anthropometric and dietary outcomes. H2: AVOID will produce changes in the home food environment and RESIST will operate on inhibitory control. Aim 3 (Moderators). Examines how (a) individual characteristics (age, sex, ethnicity, socioeconomic status, household composition, physical activity, baseline BMI and executive functioning), and (b) process data (frequency of grocery delivery, dining out and take out, impulse control training and WW app use) moderate the relationship between study arms and anthropometric and dietary outcomes. These considerations are important to help explain heterogeneity in intervention outcomes and to understand who benefits from AVOID and/or RESIST.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

503

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

    • California
      • Los Angeles, California, Estados Unidos, 90069
        • Cedars-Sinai Medical Center

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

14 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria (Main participants):

  • Age 18 years or older
  • BMI between 25-45 kg/m2
  • Read, write, and speak English with acceptable visual acuity
  • Has a household member (≥ 14 years) willing to complete three brief assessments over 12 months* *Only applies to individuals who indicate they are cohabitating with at least one eligible household member

Inclusion Criteria (Household participants):

  • 14-years-old
  • Parent consent for children <18-years-old
  • Willingness to complete assessments / measurements

Exclusion Criteria (Main participants):

  • Currently enrolled in weight loss interventions or undergoing bariatric surgery
  • Pregnant women
  • Individuals for whom weight loss may be contraindicated (e.g., unstable coronary artery disease, end-stage disease, active cancer treatment, uncontrolled insulin-dependent diabetes, portal hypertension, drug/alcohol abuse)
  • Individuals with severe cognitive delays or visual/hearing impairment
  • Individuals who are unable or unwilling to complete the study assessments / measurements

Exclusion Criteria (Household participants):

  • ≤ 14-years-old
  • Individuals who are unable or unwilling to complete the study assessments / measurements

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: WW Only

WW is commercially-available weight management program focusing on diet, physical activity and mindset skills.

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Experimental: WW + Home modification and grocery delivery (AVOID)

WW + modification of home food environment + online grocery shopping and delivery

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Participants (Arms 2 & 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

Experimental: WW + Inhibitory control training (RESIST)

WW + daily gamified inhibitory control training

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Participants assigned to RESIST (Arms 3 & 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

Experimental: WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)

WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Participants (Arms 2 & 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

Participants assigned to RESIST (Arms 3 & 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in BMI from baseline to 12 months.
Periodo de tiempo: Baseline, 6-month, 12-month

BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline, 6- and 12-months.

Baseline, 6-month, 12-month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diet quality assessed by 24h-dietary recall
Periodo de tiempo: Baseline, 6-month, 12-month

Gold standard interviewer-administered, multi-pass 24h-recalls (2 weekdays, 1 weekend day) will be used to measure diet quality. The Nutrition Data System for Research software (Nutrition Coordinating Center, University of Minnesota) is used to analyze the data. Investigators will use the 24h-recalls to assess changes in participants and household members' overall diet quality, based on adherence to the dietary guidelines for fruits and vegetables, servings of whole grains, red/processed meat, alcoholic beverages and food/beverages with added sugars.

Baseline, 6-month, 12-month

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Home availability of healthy and unhealthy foods and beverages
Periodo de tiempo: Baseline, 6-month, 12-month

Participants will self-report the availability of fruits and vegetables, servings of whole grains, red/processed meat, alcoholic beverages and food/beverages with added sugars in participants' homes. Responses will be scored as availability of healthy foods and beverages (e.g., fruits and vegetables), and availability of less healthy foods and beverages (e.g., processed meat, food/beverages with added sugars).

Baseline, 6-month, 12-month
Flanker task
Periodo de tiempo: Baseline, 6-month, 12-month

Participants have 1000ms to identify which direction a central arrow is pointing. Participants complete 64 congruent and incongruent randomly mixed trials. In congruent trials flanking stimuli points in the same direction as the central stimulus while in incongruent trials flanking stimuli points in the opposite direction.

Baseline, 6-month, 12-month
Continuous Performance Task Go/No-Go
Periodo de tiempo: Baseline, 6-month, 12-month

Participants respond to a target shape (e.g. a white five-pointed star) and withhold a response from non-target shapes. In 20% of presented trials an inhibitory response will be required.

Baseline, 6-month, 12-month
Set-Shifting
Periodo de tiempo: Baseline, 6-month, 12-month

Participants categorize colored shapes by color or shape in three blocks. In the first two blocks, participants categorize shapes for 20 trials. In the third block, the categorization rules are randomly interleaved, and participants switch between rules. Participants have 1500ms to identify the stimulus and complete 96 trials with a 25% chance of rule-switching.

Baseline, 6-month, 12-month
Demographics
Periodo de tiempo: Baseline only

Participants will complete a questionnaire surveying: date of birth, sex, socioeconomic status (education level, household income, marital status, employment status), household composition (multigenerational, single, married, cohabitating, children) and race/ethnicity.

Baseline only
Executive Functioning
Periodo de tiempo: Baseline, 6-month, 12-month

The Behavior Rating Inventory of Executive Function®- Adult Version (BRIEF-A) is a standardized measure of executive functions or self-regulation in everyday environment. The BRIEF-A assesses nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. BRIEF-A is available in English and Spanish and can be computer-administered. Baseline score on the BRIEF will be tested as moderator of the relationships between study arms and outcomes.

Baseline, 6-month, 12-month
WW Process Data
Periodo de tiempo: monthly between baseline and 12-month

Interactions such as tracked food, weight and activity in WW app will be passively recorded to operationalize engagement. A higher score indicates greater engagement.

monthly between baseline and 12-month
Grocery Delivery Process data
Periodo de tiempo: monthly between baseline and 12-month

Frequency of grocery delivery and dining out/take out will be recorded through participants' self-report of grocery delivery. Higher frequencies of grocery delivery indicates greater engagement.

monthly between baseline and 12-month
PolyRules! Process data
Periodo de tiempo: monthly between baseline and 12-month

Frequency/duration of gamified cognitive training will be passively recorded by the PolyRules! app. Greater frequency and duration indicate greater engagement.

monthly between baseline and 12-month
Physical activity
Periodo de tiempo: Baseline, 6-month, 12-month

The International Physical Activity Questionnaire (IPAQ) will be used to assess activity in 5 domains: job-related; transportation; housework, house maintenance, and caring for family; recreation, sport, and leisure-time physical activity; and time spent sitting. Data conferred by the WW program will also be leveraged, as participants track their activity (type, duration and intensity) via the WW mobile app or online website. Investigators will examine how engagement in exercise and daily activities moderate the relationships between study arms and outcomes.

Baseline, 6-month, 12-month
Eating attitudes
Periodo de tiempo: Baseline, 6-month, 12-month

The Dutch Eating Behavior Questionnaire (DEBQ) will be used to assess participants' approach to food and eating along three dimensions: emotional, external and restricted eating. There is a high degree of stability for each of these three eating behavior scales. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

Baseline, 6-month, 12-month
Food Security Questionnaire
Periodo de tiempo: Baseline only

The Food Security Questionnaire will be used to evaluate the availability of nutritious and safe foods for participants and their households at all times. The questionnaire will assess the household's ability to meet their food needs and will determine their placement on a food security continuum based on their responses to a series of questions. Researchers will analyze how food security impacts the relationships between different study arms and the outcomes.

Baseline only
Changes in Health and Lifestyle.
Periodo de tiempo: 6-month, 12-month

Changes in health, medication, diet, and exercise among participants will be assessed via routine questionnaires administered at specific study time points (e.g., 6 and 12 months). The study team will monitor reported changes on an ongoing basis. Any data indicating potential new exclusion criteria (e.g., a diagnosis of cancer or other serious conditions) will be reviewed on a case-by-case basis. If the data meet the criteria for New Reportable Information (NRI), such as adverse events or single-subject exemptions, the appropriate reporting procedures will be followed according to IRB guidelines.

6-month, 12-month
Participant Experience Interview
Periodo de tiempo: withdrawal or 6-month and 12-month

Main participants will be asked to complete a brief semi-structured participant experience interview at 6 months and at the conclusion of their intervention (either at withdrawal or 12-months). The interview will be conducted online via Zoom or MS Teams and last between 10-15 minutes. The questions asked will vary depending on the intervention arm.

withdrawal or 6-month and 12-month

Colaboradores e Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

6 de junio de 2022

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

21 de noviembre de 2021

Publicado por primera vez (Actual)

3 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de octubre de 2026

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

15 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00001652
  • 1R01DK130851-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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

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. .

Suscribir