Optimization of Dietary Adherence in a Mobile Weight Loss Intervention
13 de mayo de 2026 actualizado por: UNC Lineberger Comprehensive Cancer Center
Optimizing Dietary Adherence in a Mobile Behavioral Weight Loss Intervention for Adults
The goal of this study is to test multiple individual treatment components added to a 6-month standard mobile behavioral weight loss program that are intended to help participants follow dietary recommendations and meet their dietary goals more often.
The four components to be studied include switching dietary tracking methods, receiving access to a goal planning tool, receiving additional personalized text messages, and receiving three sessions with a health coach.
The study will identify the best combination of these additional treatments for improving total number of weeks in the program that participants meet their dietary goals.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
SHIFT uses a highly efficient experimental design as part of the Multiphase Optimization Strategy (MOST) to optimize a 6-month behavioral weight loss intervention for improved dietary adherence among adults with overweight and obesity with initial nonresponse to the intervention. Investigators will test four unique treatment components added to a core mobile behavioral weight loss program.
All participants will receive the Core 6-month behavioral weight loss program, which is a comprehensive intervention that includes evidence-based behavior change strategies to promote self-monitoring and adherence to personalized dietary and activity goals. The program includes an individual kick-off session, native smartphone application, text messages, daily goals, self-monitoring of diet, weight, and physical activity, weekly lessons, tailored weekly feedback, and will start with 5-6 text messages per week. The intervention targets both dietary and physical activity changes, with a greater emphasis placed on improved dietary behaviors as the primary strategy for weight loss. Participants with lower than expected adherence to their dietary goals early in the program (weeks 3-8; "nonresponders") will be randomly assigned in a 2x2x2x2 factorial trial to the On or Off level of each of these 4 additional treatments added onto the core program: 1) switching dietary self-monitoring approach (Simplified Diet), 2) adding an autonomous goals and planning tool (Goal Autonomy + Planning), 3) adding just-in-time text messaging (JIT Messaging) 4) receiving 3 telehealth sessions with a health coach (Coach). Thus, each of these participants will receive 0-4 additional treatment components for the remainder of the 6-month program. Participants with recommended levels of dietary adherence in the first 8 weeks ("responders") remain in the Core program and are not randomized in the factorial trial.
All participants (those in the factorial trial and the responders who remain in the Core only) will complete assessments at baseline, 4 weeks (brief/online only), 8 weeks (brief/online only), 3 months, and 6 months. Primary and secondary research aims are limited to participants who are randomized into the factorial trial (estimated to be approximately 65% of the total sample). The primary aim is to determine the combination of additional intervention components that maximize dietary adherence from time of randomization to 6 months among participants with low early dietary adherence. A secondary outcome is percent of participants reaching 5% weight loss from baseline to 6 months.
Decision analysis for intervention value efficiency (DAIVE) will be the decision-making approach used to select the treatment components included in the final, optimized intervention. DAIVE uses a Bayesian factorial analysis of variance that maximizes the expected value of the outcome by evaluating the predicted value associated with all possible combinations of the components. DAIVE will be used maximize the expected value of both mean total weeks of dietary adherence from randomization to 6 months and proportion reaching 5% weight loss at 6 months.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
580
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.
Estudio Contacto
- Nombre: Brooke T Nezami, PhD
- Número de teléfono: 2 919-966-5852
- Correo electrónico: bnezami@unc.edu
Copia de seguridad de contactos de estudio
- Nombre: Karen E Hatley, MPH
- Número de teléfono: 2 919-966-5852
- Correo electrónico: keericks@email.unc.edu
Ubicaciones de estudio
-
-
North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina at Chapel Hill
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Investigador principal:
- Brooke T Nezami, PhD
-
Contacto:
- Karen E Hatley, MPH
- Número de teléfono: 2 919-966-5852
- Correo electrónico: keericks@email.unc.edu
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- BMI 25-50 kg/m2 at baseline
- Own a smartphone with an active data and text messaging plan
- English-speaking and writing
- Willing to be randomized to any of the additional treatment components
Exclusion Criteria:
- Lost 5% or more of body weight (and kept it off) in the last 3 months
- Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
- Current symptoms of alcohol or substance dependence
- Currently pregnant, pregnant within the past 6 months, currently breastfeeding, or planning to become pregnant within the next 6 months
- Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
- Hospitalization for depression or other psychiatric disorders within the past 12 months
- History of psychotic disorder or bipolar disorder
- Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
- Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), except individuals on a stable dose of SSRIs for 3 months
- Current use of bone acting medications (e.g., raloxifene, calcitonin, parathyroid hormone during the past year, PTH-analogues [e.g., teriparatide, abaloparatide], sclerostin inhibitors (romosozumbab), RANK ligand inhibitors (denosumab) or bisphosphonates during the last two years
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4)
- Report a health condition for which the program's dietary and physical activity recommendations would be unsafe, including hospitalization for heart failure, myocardial infarction or stroke in the past year, chronic kidney disease stage IV or V, liver failure or cirrhosis, chronic obstructive pulmonary disease on oxygen or requiring steroids, osteoporosis on medication, sarcopenia, history of fragility fractures, or dementia
- Other health problems that may influence the ability to walk for physical activity or be associated with unintentional weight change, including current cancer diagnosis, cancer treatment within the past 5 years or tuberculosis
- Previous surgical procedure for weight loss or planned weight loss surgery in the next year
- Another member of the household is a participant or staff member on this trial
- Ability to provide consent (4 items adapted from the UBACC [University of California, San Diego Brief Assessment of Capacity to Consent])
- Reason to suspect that the participant would not adhere to the study intervention
- Does not live in the United States
- Cannot have participated in a research study conducted by UNC Weight Research Program in the past 2 years
Individuals endorsing joint problems, current treatment for hypertension or hyperlipidemia, or osteoporosis diagnosis not on medication will be required to obtain written physician consent to participate.
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 factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Condition 1
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 2
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
Experimental: Condition 3
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 4
Core + Switch to Simplified Diet Monitoring + Goal Autonomy/Planning
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
|
|
Experimental: Condition 5
Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 6
Core + Switch to Simplified Diet Monitoring + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
Experimental: Condition 7
Core + Switch to Simplified Diet Monitoring + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 8
Core + Switch to Simplified Diet Monitoring
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Switch from standard detailed calorie tracking to a simplified diet self-monitoring approach in which participants track red foods using a color-coded traffic light system.
|
|
Experimental: Condition 9
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 10
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
Experimental: Condition 11
Core with Standard Diet Monitoring + Goal Autonomy/Planning + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 12
Core with Standard Diet Monitoring + Goal Autonomy/Planning
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
A weekly goal planning tool that allows participants to adjust their dietary goals and make a specific plan for the week.
|
|
Experimental: Condition 13
Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 14
Core with Standard Diet Monitoring + Just-in-time (JIT) Messaging
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Increased frequency of text messages (1-2 per day), highly personalized based on past and current dietary adherence and weight change.
|
|
Experimental: Condition 15
Core with Standard Diet Monitoring + Coach Sessions
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
Receive 3 brief telephone or video coach sessions (20-30 minutes) every other week following randomization.
|
|
Experimental: Condition 16
Core with Standard Diet Monitoring
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
|
|
Otro: Core Only (Responders)
Core program (participants who are not randomized in the factorial intervention)
|
Behavioral weight loss core includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; 5-6 text messages per week.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total weeks of dietary goal adherence
Periodo de tiempo: Time of randomization to 6 months
|
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met ≥ 3 days/week (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
|
Time of randomization to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent of participants reaching >= 5% weight loss
Periodo de tiempo: Baseline to 6 months
|
Scale weights at baseline and 6 months will be used to calculate, among nonresponders randomized into the factorial trial, percent weight change ( [(weight at 6 months - baseline weight) / baseline weight] × 100) and classify participants as achieving or not achieving at least 5% weight loss.
|
Baseline to 6 months
|
|
Total days of dietary goal adherence
Periodo de tiempo: Time of randomization to 6 months
|
Objective self-monitoring of dietary intake (pulled via the Fitbit API for those in the conditions with standard dietary self-monitoring and the Traffic Light Log app API for the those in conditions that switch to simplified dietary self-monitoring) will be used to calculate, among nonresponders randomized into the factorial trial, number of days after randomization in which the dietary goal (calorie goal or red food goal) was met (the daily dietary goal is defined as a complete day of tracking and ≤ the calorie/red food goal).
|
Time of randomization to 6 months
|
|
Weight Change (kg)
Periodo de tiempo: Baseline, 6 months
|
Estimated mean weight change in kg from baseline to 6 months among nonresponders randomized into the factorial trial.
More negative values of weight change indicate greater weight loss.
Weights will be objectively measured in light clothes, without shoes, on the digital smart scales in participants' homes.
|
Baseline, 6 months
|
|
Dietary intake
Periodo de tiempo: Baseline, 3 months, 6 months
|
Diet will be assessed using the self-administered National Cancer Institute's Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, a free, web-based tool for 24-hour recalls.
Participants will complete unscheduled recalls on a weekday and a weekend day at each timepoint.
Change in average total kcals/day will be calculated among nonresponders randomized into the factorial trial.
Changes are calculated as (average daily kcal at 3/6 months - average daily kcal at baseline).
|
Baseline, 3 months, 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Estimado)
1 de marzo de 2027
Finalización primaria (Estimado)
1 de septiembre de 2029
Finalización del estudio (Estimado)
1 de octubre de 2029
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-1211
- R01HL178992 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Deidentified individual data that supports the primary outcome results will be made available through the UNC Dataverse (https://dataverse.unc.edu/).
Criterios de acceso compartido de IPD
The shared data will have a persistent unique identifier (DOI) from the UNC Dataverse repository.
The data will also be discoverable online through a standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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. .