Viewing Study NCT00225888



Ignite Creation Date: 2024-05-05 @ 12:03 PM
Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00225888
Status: TERMINATED
Last Update Posted: 2017-04-13
First Post: 2005-09-22

Brief Title: Feasibility Study of Digital Photography and Group Discussion for People With Diabetes
Sponsor: Joslin Diabetes Center
Organization: Joslin Diabetes Center

Study Overview

Official Title: Digital Photography and Group Discussion as a Means of Affecting Dietary Change Among People With Type 2 Diabetes Feasibility Project
Status: TERMINATED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Investigators left Joslin
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to compare the effect of food photography with group discussions to the effect of regular diabetes nutrition care on peoples eating habits satisfaction with care self-care behaviors and blood sugar levels We hypothesize that by photographing all meals and snacks ie keeping photo journals and participating in discussions about the photographs with peers and a nutritionist people with diabetes will become aware of their behaviors and develop concrete strategies to meet nutritional recommendations
Detailed Description: Diet is critical to effective self-management of diabetes Thus people with diabetes receive substantial nutrition counseling as part of their care Among other things nutrition counseling can include nutrition facts information about portions menus discussion of barriers to healthy eating and recommendations to control intake of saturated fats maintain consistent eating patterns and distribute nutrient intake throughout the day Despite the depth and breadth of nutrition counseling many people with diabetes implement diet changes with limited success

The overall objective of this study is to test the feasibility of a new approach to diabetes nutrition care digital food photography and facilitated group discussions The overall hypothesis regarding this new approach is that by photographing all meals and snacks ie keeping photo journals and participating in discussions about the photographs with peers and a nutritionist people with diabetes will become aware of their behaviors and develop concrete strategies to meet nutritional recommendations This overall hypothesis can be further specified as follows

People with diabetes who receive the new approach to diabetes nutrition care ie the digital photos with discussions will show greater improvements in their nutritional profiles and hemoglobin A1c HbA1c values primary clinical outcomes than people who receive standard diabetes nutrition care
People with diabetes who receive the new approach to diabetes nutrition care will become more satisfied with their diabetes treatment compared to people who receive standard care secondary clinical outcome
People with diabetes who receive the new approach to diabetes nutrition care will show greater improvements in minimizing the barriers that affect their abilities for effective self-care compared to people who receive standard care secondary outcome

The study design is that of a single-site randomized controlled trial with two groups of approximately 18 study participants assigned to each for a total of 36 study participants The study will take place at Joslin Diabetes Center One group will receive standard diabetes nutrition care The other group will receive the new approach to diabetes nutrition care involving digital photography of meals and group discussion of the photographs All participants will complete study questionnaires before the study begins and approximately 1 month after the completion of the digital photography discussion groups

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DAMD17-03-2-0062 None None None