NCT04660851CompletedNot Applicable
Improving Diet Protein Intake in Middle-aged Women
Florida Atlantic University1 site in 1 country54 target enrollmentStarted: June 26, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Florida Atlantic University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Changes in dietary protein intake from baseline
Study Overview
Brief Summary
The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.
Detailed Description
The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •able to understand and respond to questions or instructions in English
- •working telephone
- •willingness to consume protein-containing animal products,
- •willingness to make changes to the diet
Exclusion Criteria
- •self-reported information that they have been told by a medical doctor that they have kidney (renal) disease
- •current or past history of a diagnosed eating disorder
- •have an internal cardiac pacemaker/defibrillator or other metal-type implant present
- •vegan dietary practices
- •refusal to make changes to usual dietary protein intake
- •usual dietary protein intake greater than 1.2 g per kg body weight
Arms & Interventions
Not-coached
No Intervention
No coaching provided
Coached
Experimental
10 weeks of diet coaching
Intervention: Coached (Behavioral)
Outcomes
Primary Outcomes
Changes in dietary protein intake from baseline
Time Frame: 12 weeks
Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.
Secondary Outcomes
- Changes in upper body muscle strength(12 weeks)
- Changes in muscle mass(12 weeks)
- Changes in lower body muscle strength and function(12 weeks)
- Changes in muscle function(12 weeks)
Investigators
Sareen Gropper, PhD, RDN, LDN
Professor
Florida Atlantic University
Study Sites (1)
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