Clinical Trials Logo

Clinical 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 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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. 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: I. 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: I. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02194387
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date September 17, 2014
Completion date September 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Terminated NCT03299881 - Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss N/A
Completed NCT02805478 - Fat-Associated Cardiovascular Organ Dysfunction
Active, not recruiting NCT02558920 - Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
Completed NCT03759743 - Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject N/A
Completed NCT03610958 - Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss. N/A
Completed NCT03678766 - CHARGE: Controlling Hunger and ReGulating Eating N/A
Completed NCT04430465 - Effects of Wholegrains on Children's Health (KORN) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05376865 - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers N/A
Completed NCT03625427 - Effect of Palmitoleic Acid on C-reactive Protein N/A
Active, not recruiting NCT03435445 - Online Platform for Healthy Weight Loss (POEmaS) N/A
Enrolling by invitation NCT05576116 - Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Active, not recruiting NCT06023095 - A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities Phase 1
Completed NCT03648892 - Brain Dopamine Function in Human Obesity Early Phase 1
Not yet recruiting NCT05751993 - Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions N/A
Recruiting NCT02887950 - Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause N/A
Completed NCT02829229 - Community-based Obesity Treatment in African American Women After Childbirth N/A
Terminated NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4