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OpenTrials
Completed

NCT Number: NCT02871388

Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

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.

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Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Breast Cancer Risk Factors Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 40-65 years of age,
  • Received a negative mammography screening result in the previous four weeks
  • Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
  • Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
  • BMI 25-40 kg/m2
  • Has access to a computer or mobile device with wireless internet
  • Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion criteria

  • Previous history or current diagnosis of breast cancer
  • Pregnancy or lactation
  • Involvement in a weight loss program
  • Major co-morbidities (e.g.,diabetes, hypertension, etc.)
  • History of disordered eating
  • Currently taking medication that may impact weight (e.g., synthroid, metformin)

Treatment and study plan

CONECT

Behavioral

1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.

Primary outcomes

  1. feasibility-participant engagement and retention

    Time frame: 12 weeks

    recruitment of 30 participants with 70% retention at 12 weeks

  2. feasibility-intervention adherence

    Time frame: 12 weeks

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

Secondary outcomes

  1. Change in autonomous motivation

    Time frame: 12 weeks and 24 weeks

    Motivation assessment and feedback.

  2. Steps per day

    Time frame: 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

    Time frame: 12 and 24 weeks

    assessed by 7 day Physical Activity Recall Scale (PAR)

  4. Daily caloric goals

    Time frame: 12 and 24 weeks

    assessed by Automated Self-Administered (ASA) 24

Other outcomes

  1. change in waist circumference

    Time frame: 12 and 24 weeks

    waist circumference measured at 12 and 24 weeks.

  2. weight loss

    Time frame: 12 weeks

    percent weight loss at 12 weeks

  3. weight maintenance

    Time frame: 24 weeks

    for intervention group only, percent weight loss at 24 weeks

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2016
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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