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Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

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EstadoTerminado
Patrocinadores
Virginia Commonwealth University

Palabras clave

Abstracto

The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.

fechas

Verificado por última vez: 06/30/2019
Primero enviado: 08/14/2016
Inscripción estimada enviada: 08/14/2016
Publicado por primera vez: 08/17/2016
Última actualización enviada: 07/07/2019
Última actualización publicada: 07/08/2019
Fecha de inicio real del estudio: 05/29/2017
Fecha estimada de finalización primaria: 02/27/2019
Fecha estimada de finalización del estudio: 02/27/2019

Condición o enfermedad

Weight Loss
Breast Cancer Risk Factors

Intervención / tratamiento

Behavioral: CONECT

Fase

-

Grupos de brazos

BrazoIntervención / tratamiento
Experimental: CONECT
12 week program with additional follow up at 24 weeks.
Behavioral: CONECT
1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
No Intervention: Control
Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks.

Criterio de elegibilidad

Edades elegibles para estudiar 40 Years A 40 Years
Sexos elegibles para estudiarFemale
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

1. Female

2. 40-65 years of age,

3. Received a negative mammography screening result in the previous four weeks

4. Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),

5. Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).

6. BMI 25-40 kg/m2

7. Has access to a computer or mobile device with wireless internet

8. Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion Criteria:

1. Previous history or current diagnosis of breast cancer

2. Pregnancy or lactation

3. Involvement in a weight loss program

4. Major co-morbidities (e.g.,diabetes, hypertension, etc.)

5. History of disordered eating

6. Currently taking medication that may impact weight (e.g., synthroid, metformin)

Salir

Medidas de resultado primarias

1. feasibility-participant engagement and retention [12 weeks]

recruitment of 30 participants with 70% retention at 12 weeks

2. feasibility-intervention adherence [12 weeks]

Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions

Medidas de resultado secundarias

1. Change in autonomous motivation [12 weeks and 24 weeks]

Motivation assessment and feedback.

2. Steps per day [12 and 24 weeks]

participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity.

3. Total minutes of weekly physical activity [12 and 24 weeks]

assessed by 7 day Physical Activity Recall Scale (PAR)

4. Daily caloric goals [12 and 24 weeks]

assessed by Automated Self-Administered (ASA) 24

Otras medidas de resultado

1. change in waist circumference [12 and 24 weeks]

waist circumference measured at 12 and 24 weeks.

2. weight loss [12 weeks]

percent weight loss at 12 weeks

3. weight maintenance [24 weeks]

for intervention group only, percent weight loss at 24 weeks

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