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Eat Well Live Well Nutrition Program

Phase 2

Diabetes or Diabetes Prevention | Unknown | Metabolic |Grace Therapeutics, Inc.|Last Updated: Jan 15, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment398
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00561158Eat Well Live Well Nutrition ProgramPHASE2 COMPLETED 398 — — Jun 1, 1994May 1, 1998Jan 15, 2010 - —
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Study Endpoints
Primary Endpoints
Weight & Body Mass Index (BMI)
pre-, post and three month follow-up
Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
Secondary Endpoints
Depressive symptoms (C-ESD)
pre-, post and three month follow-up
Dietary Knowledge: ten items that test knowledge of: i) fat in foods that are specific to target population; ii) Label Reading; iii) modifying recipes to lower fat content; and iv) saturated versus unsaturated fats
pre-, post and three month follow-up
Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry
pre-, post and three month follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
2NO_INTERVENTION -
Interventions
NameTypeDescription
Eat Well Live Well Nutrition ProgramBEHAVIORAL12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information. The group sessions included are: * Rate Your Plate: determining high fat foods * Label Reading: reading food labels * Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income * Recipe Modification: preparing old recipes in new ways to reduce fat * Eating Out: order healthier fast foods * Coping with High Risk Situations: coping with situations in which these new habits may be threatened Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including: * Substituting fat-modified foods for high fat foods * Avoiding fat as a seasoning or flavoring * Avoiding fried foods * Modifying meat * Replacing high fat foods with fruits, vegetables, grains and breads
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Eligibility Criteria
Age Range25 Years — 55 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * African-American Women * Aged 25-55 years * No current diabetes, obese (20% over ideal body weight) * In community neighborhoods

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