A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes
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|ClinicalTrials.gov Identifier: NCT03896360|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes Obesity||Behavioral: Food order behavioral intervention plus standard care Behavioral: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes|
|Actual Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: Food order behavioral intervention plus standard care
Subjects will receive standard nutrition counseling and additional carbohydrate‐last food order behavioral counseling.
Behavioral: Food order behavioral intervention plus standard care
Subjects in the Food order behavioral intervention plus standard care will receive standard counseling by a registered dietitian and additional carbohydrate last food order behavioral counseling by a member of the research team at baseline and Weeks 4, 8 and 12.
Subjects will receive standard nutrition counseling.
Behavioral: Standard Care
Subjects will receive standard counseling by a registered dietitian at the baseline visit. Standard counseling will be similarly reinforced at weeks 4, 8 and 12.
- Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes [ Time Frame: 16 weeks ]Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes as measured by the proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896360
|United States, New York|
|Comprehensive Weight Control Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Anthony Casper 646-962-2424 firstname.lastname@example.org|
|Principal Investigator: Alpana P Shukla, MD|
|Principal Investigator:||Alpana P Shukla, MD||Weill Cornell Medicine|