NCT04660851

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

October 16, 2020

Last Update Submit

December 7, 2020

Conditions

Dietary Habits

Keywords

Protein intake, coaching, strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in muscle mass

    12 weeks

  • Changes in upper body muscle strength

    12 weeks

  • Changes in lower body muscle strength and function

    12 weeks

  • Changes in muscle function

    12 weeks

Study Arms (2)

Coached

EXPERIMENTAL

10 weeks of diet coaching

Behavioral: Coached

Not-coached

NO INTERVENTION

No coaching provided

Interventions

CoachedBEHAVIORAL

10-weeks of diet coaching weekly by telephone to improve dietary protein intake

Coached

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Sareen S Gropper, PhD

    Professor, College of Nursing, Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2020

First Posted

December 9, 2020

Study Start

June 26, 2019

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)