NCT05640869

Brief Summary

The purpose of this study is to demonstrate the efficacy of the diabetes prevention program for the treatment of overweight and obesity within the community pharmacy setting. The long-term goal is to demonstrate the potential to improve diabetes prevention efforts through expanded access to weight loss services provided in community pharmacies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 22, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

August 22, 2022

Last Update Submit

April 24, 2023

Conditions

Weight LossPreDiabetes

Keywords

community pharmacy

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    Change from baseline body weight

    6 months

  • Change in A1c

    Change from baseline A1c

    3- and 6- months

Secondary Outcomes (3)

  • Proportion of patients meeting DPP program criteria

    From enrollment, assessed once enrollment is complete, within 3 months of study start.

  • Blood pressure change

    6 months

  • Physical activity change

    6 months

Other Outcomes (5)

  • Participation and attrition

    6 months

  • Reasons for participation/non-participation

    1 year

  • Change in level of confidence in ability to motivate oneself to maintain dietary and physical activity behaviors for at least 6 months

    6 months

  • +2 more other outcomes

Study Arms (1)

Modified DPP

EXPERIMENTAL

Participants in this arm will participate in the modified Diabetes Prevention Program curriculum.

Behavioral: Modified Diabetes Prevention Program Curriculum

Interventions

Modified Diabetes Prevention Program CurriculumBEHAVIORAL

The modified DPP curriculum will be an exact copy of the current DPP curriculum except that references to the prevention of diabetes will be modified to prevention of health outcomes associated with overweight/obesity and/or management of overweight/obesity.

Modified DPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old
  • BMI ≥ 25kg/m2 (23 if Asian)

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (6)

  • Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.

    PMID: 22683128BACKGROUND

  • Venkataramani M, Pollack CE, Yeh HC, Maruthur NM. Prevalence and Correlates of Diabetes Prevention Program Referral and Participation. Am J Prev Med. 2019 Mar;56(3):452-457. doi: 10.1016/j.amepre.2018.10.005. Epub 2019 Jan 17.

    PMID: 30661888BACKGROUND

  • Joiner KL, McEwen LN, Hurst TE, Adams MP, Herman WH. Domains from the health belief model predict enrollment in the National Diabetes Prevention Program among insured adults with prediabetes. J Diabetes Complications. 2022 Jul;36(7):108220. doi: 10.1016/j.jdiacomp.2022.108220. Epub 2022 May 17.

    PMID: 35613987BACKGROUND

  • Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8.

    PMID: 30044214BACKGROUND

  • Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.

    PMID: 3432232BACKGROUND

  • Andres A, Saldana C, Gomez-Benito J. Establishing the stages and processes of change for weight loss by consensus of experts. Obesity (Silver Spring). 2009 Sep;17(9):1717-23. doi: 10.1038/oby.2009.100. Epub 2009 Apr 9.

    PMID: 19360014BACKGROUND

Related Links

MeSH Terms

Conditions

Weight LossPrediabetic State

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Courtney E Gamston, PharmD

    Auburn University Harrison School of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experiential Practice

Study Record Dates

First Submitted

August 22, 2022

First Posted

December 7, 2022

Study Start

February 7, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)