Body Mass Index 25 or GreaterNCT02194387
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
A study testing Dietary Intervention, Internet-Based Intervention and Laboratory Biomarker Analysis in people with Body Mass Index 25 or Greater and BRCA1 Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- Dietary Intervention, Internet-Based Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2014to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PILOTS I, II AND III: Body mass index (BMI) of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR < 5 servings of fruit and vegetables per day
- PILOTS I, II AND III: Capable of participating in moderate-vigorous unsupervised exercise
- PILOTS I, II AND III: Have a cellular telephone and are able and willing to send and receive text messages
- PILOTS I, II AND III: Able to read and write English
- PILOTS I, II AND III: Have access to internet
- PILOT II: BRCA positive OR Lynch syndrome positive individuals
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- PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
- PILOT III: CLL survivors
- PILOT III: Has experienced fatigue within the past seven days
Who cannot join
- PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
- PILOTS I, II AND III: Women who are pregnant (by self-report)
- PILOTS I, II AND III: Less than 3 months post-surgery
- PILOTS II and III: Currently receiving radiation therapy or cytotoxic chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Tests to Optimize the Delivery of Energy Balance Interventions
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
Read the detailed description
PRIMARY OBJECTIVES:
- To explore the feasibility of using the multi-phase optimization strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees. (Pilot I) II. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer)-positive and Lynch syndrome positive individuals and their family members. (Pilot II) III. To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (chronic lymphocytic leukemia) patients. (Pilot III)
SECONDARY OBJECTIVES:
- To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot I) II. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot II) III. To develop preliminary estimates of effect size and outcome variability for use in planning future studies. (Pilot III)
EXPLORATORY OBJECTIVES:
- To examine relationship between individual-level (e.g., distress) and family-level (e.g., shared mutation status) variables that are specific to high-risk families and the effectiveness of energy balance interventions. (Pilot II)
OUTLINE: Participants are assigned to 1 condition in each component for a total of 16 groups using a randomized factorial design.
TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone application (app).
After completion of study, patients are followed up at 4 months.
- Conditions
- Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma, Cancer Survivor, Chronic Lymphocytic Leukemia
- Being tested
- Dietary Intervention, Internet-Based Intervention, Laboratory Biomarker Analysis, Questionnaire Administration, Telephone-Based Intervention
- Medical subject headings
- Breast Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Fatigue, Colorectal Neoplasms, Hereditary Nonpolyposis, Ovarian Neoplasms, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Record dietary intake 4-7 days per week
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Record dietary intake 1 day per week
Internet-Based InterventionOther
Receive email coaching
Internet-Based InterventionOther
Participate in social networking
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive telephone coaching
Telephone-Based InterventionBehavioural
Receive text messages
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (energy balance interventions) | Experimental | TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing.
TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages.
SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking.
SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app. Receives: Dietary Supplement: Dietary Intervention; Other: Internet-Based Intervention; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in waist circumference (Pilot I)
Expressed as the mean difference.
Measured: Baseline to 4 months post-intervention
Change in waist circumference (Pilot II)
Expressed as the mean difference.
Measured: Baseline to 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start17 Sep 2014
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Mass Index 25 or GreaterStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen M Basen-Engquist, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194387
- Sponsor's protocol ID
- 2014-0230
- Other IDs
- NCI-2015-00095, 2014-0230
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2014
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Crane JC, Gordon MJ, Basen-Engquist K, Ferrajoli A, Markofski MM, Lee CY, Fares S, Simpson RJ, LaVoy EC. Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Eur J Haematol. 2023 Jun;110(6):732-742. doi: 10.1111/ejh.13958. Epub 2023 Mar 31.
PubMed 36946440