Overweight Clinical Trial
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.
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. ;
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 | |
Terminated |
NCT02796144 -
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
|
Phase 4 | |
Completed |
NCT02829229 -
Community-based Obesity Treatment in African American Women After Childbirth
|
N/A |