Improving Diet Protein Intake in Middle-aged Women

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.

Study Overview

• Status: Completed
• Conditions: Dietary Habits
• Intervention / Treatment: Behavioral: Coached

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Florida Atlantic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coached; 10 weeks of diet coaching	Behavioral: Coached; 10-weeks of diet coaching weekly by telephone to improve dietary protein intake
No Intervention: Not-coached; No coaching provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in dietary protein intake from baseline	Assessed changes in dietary protein intake from three 24-hour dietary recalls collected at baseline.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle mass	Changes in muscle mass from baseline were measured using bioelectrical impedance analysis	12 weeks
Changes in upper body muscle strength	Changes in handgrip strength from baseline were measured using hand dynamometer	12 weeks
Changes in lower body muscle strength and function	Changes in 5-chair stand times from baseline were assessed	12 weeks
Changes in muscle function	Changes in 4 meter gait speed from baseline were assessed	12 weeks

Collaborators and Investigators

• Sponsor: Florida Atlantic University
• Investigators: Principal Investigator: Sareen S Gropper, PhD, Professor, College of Nursing, Florida Atlantic University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Protein intake, coaching, strength
• Other Study ID Numbers: 1440147-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No