NCT00225888

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 people's eating habits, satisfaction with care, self-care behaviors, and blood sugar levels. We hypothesize that, by photographing all meals and snacks (i.e., 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2007

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

September 22, 2005

Last Update Submit

April 12, 2017

Conditions

Type 2 Diabetes

Keywords

DiabetesNutritionDigital photographySelf-management

Outcome Measures

Primary Outcomes (2)

  • Subjects' nutritional profiles

    6 months

  • Subjects' hemoglobin A1c (A1c) values

    6 months

Secondary Outcomes (2)

  • Subjects' satisfaction with diabetes treatment

    6 months

  • Subjects' self-care behaviors

    6 months

Interventions

Digital Photography of meals/snacks and group discussionBEHAVIORAL

Digital Photography of meals/snacks and group discussion

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be a patient of the Joslin Diabetes Center
  • Must have type 2 diabetes
  • Must be between 30 and 60 years of age
  • Must have a BMI equal to or greater than 30
  • Must agree to randomization
  • Must provide written informed consent

You may not qualify if:

  • Unable to give written informed consent
  • Unable to communicate in and read English
  • A severe visual impairment
  • Pregnancy
  • Non-compliance or unlikely to return for the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Snacks

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stephanie J. Fonda, Ph.D.

    Joslin Diabetes Center and Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

October 1, 2004

Primary Completion

July 20, 2007

Study Completion

July 20, 2007

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)