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Purpose

This is a 17 - week study consisting of a one - week run - in period and a 16 - week intervention. The 16 - week pilot interventions aims to increase hydration in those beginning GLP - 1 RA therapy. Investigators aim to increase hydration to potentially decrease side effect severity, amount of side effects, and drug discontinuation associated with GLP - 1 RA therapy. The investigators are piloting to assess feasibility and preliminary efficacy of the intervention through examining participant retention, participant feedback, researcher and participant adherence to protocols, impact on hydration biomarkers, and participant reported GLP - 1 RA side effects.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18-60 - Recently prescribed a GLP-1RA (within one week of prescription) - Fluent in English - Willing to complete the study protocol

Exclusion Criteria

  • Children and adults > 60 years of age - Those not taking a GLP-1RA - Those who have been on a GLP-1RA longer than one week - Not fluent in English - Those who are pregnant or planning on becoming pregnant during the duration of the study - Unwilling to comply with study protocol - People with cardiac implants

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomly assigned to either the control group or the hydration plus (experimental) group. The hydration plus group will receive the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and follow a contingency management payment schedule. The control group will not engage in those behavior change strategies listed prior, but will receive the same information and complete all of the same daily and weekly tasks.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control 		Participants assigned to the control group will receive all information as the Hydration Plus (experimental) group, but will not receive any behavior change strategies or technique training/materials.
  • Behavioral: Control
    Participants randomly assigned to the control group will receive information on hydration and will receive prompts to drink.
Experimental
Hydration Plus 		The hydration plus group will receive the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and follow a contingency management payment schedule.
  • Behavioral: Hydration Plus
    The hydration plus intervention aims to increase hydration through employing the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and utilize a contingency management payment schedule wherein participant earned amount hinges on them meeting their goal.

Recruiting Locations

State University of New York at Buffalo, South Campus
Buffalo, New York 14214
Contact:
Hannah E Kolpack, BS
(716) 829 - 5820
hkolpack@buffalo.edu

More Details

Status
Recruiting
Sponsor
State University of New York at Buffalo

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.