Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00415870
Other study ID # 1R21CA115615-01A1
Secondary ID 2005-4148 UCSD N
Status Completed
Phase N/A
First received
Last updated
Start date June 2007
Est. completion date April 2009

Study information

Verified date April 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a NCI funded study which will develop and evaluate a cell phone application (mDIET) that can be used as an assessment and intervention tool to improve dietary behaviors and thus reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.


Description:

This research will develop a technologically advanced system for monitoring and intervening on diet behaviors (e.g., food intake, weight). Interventions aimed at dietary change are missing a comparable, portable tool. Mobile technologies can help fill this gap by providing portable connectivity to expert systems that create specific tailored diet goals based on participant profiles. The expert system can 'push' intervention messages throughout the day during critical point-of-decision moments to aid in decision making among users. The portable device can 'pull' information through prompts and easy-to-use recording. This ecological momentary assessment + ecological momentary intervention format may further encourage healthy behaviors by prompting at critical decision points to improve dietary behaviors.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria:

- Participants will be included if they:

- Are age 25-55

- Are overweight or moderately obese

- Are with a BMI between 25.0-34.9 (as defined by the NIH report on Obesity (NIH 1998)

- Are able to read (completion of at least the 6th grade) and speak English

- Provide consent

- Do not intend to become pregnant or move out of the county for the duration of the intervention (16 weeks).

- Participants will also be required to have a cell phone that is capable of supporting the mDIET application.

- Participants may be otherwise healthy or have one or more risk factors for CVD, including uncomplicated Type 2 diabetes but will not be enrolled if they have diagnosed CVD.

Exclusion Criteria:

Participants will be excluded from the study if they have any of the following conditions:

- An eating disorder

- Are currently pregnant

- Have a strict dietary regimen prescribed by their doctor that will not allow them to comply with intervention guidelines related to dietary changes.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Printed Material
Printed Material
Weekly Weighing
Weekly Weighing
Cell phone will serve as a self monitoring device
Cell phone will serve as a self monitoring device
Device:
Text Message
Text Message
Behavioral:
Diet Goals via Cell Phone
Diet Goals via Cell Phone
Food Monitoring
Food Monitoring

Locations

Country Name City State
United States UCSD Professional Suites La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Weight (kg) 4 months
Secondary Program Satisfaction Participants reported a 2 if they liked the program, 1 if they felt neutral about the program, and 0 if they did not like program. Higher scores reflect greater satisfaction. 4 months
Secondary Compliance With Food Monitoring Activities 4 months
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
Terminated NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4
Completed NCT02899390 - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes N/A