Remote Dietary Counseling to Promote Healthy Diet and Blood Pressure

NCT ID: NCT03700710

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2021-06-30

Brief Summary

American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines recommend lifestyle modification for patients with elevated blood pressure. While eating a Dietary Approaches to Stop Hypertension (DASH)-type diet, increasing physical activity, and weight loss have been shown to reduce blood pressure, limited resources are available in the primary care setting to help patients make these changes.

In this study, the investigators will compare the efficacy of a self-guided vs. dietitian-led approach using web-based lifestyle modification tools to reduce weight, improve dietary quality, and lower blood pressure in overweight/obese adults with elevated blood pressure.

Detailed Description

Goals that all participants will be instructed to target include: 1) weight loss >=3% at 3 months; 2) consume a healthier dietary pattern (high in fruits, vegetables, whole grains, low-fat dairy, vegetable/fish/poultry sources of protein, healthier sources of fat, and avoid sugar and salt); 3) reduce sodium intake to <2300 mg/d; 4) at least 180 min/wk of moderate-intensity physical activity.

Conditions

Blood Pressure; High Blood Pressure; Dietary Modification; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-Guided Approach

In the self-guided arm, participants will receive access to web-based tools to help achieve healthy lifestyle changes to lower their blood pressure.

The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.

Group Type: ACTIVE_COMPARATOR

Self-Guided Approach

Intervention Type: BEHAVIORAL

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.

From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.

In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.

Dietitian-led Approach

In the dietitian-led arm, dietitian will use motivational interviewing in 15-30 minute telephone calls with participants.

The web-based tools include: 1) a web-based food frequency questionnaire (Viocare FFQ), which will provide a snapshot of participants' dietary habits in the past 6 months as well as personalized recommendations for areas to improve; 2) access to an evidence-based program (Evolve, formerly BMIQ), which includes program materials for weight loss and leading a healthy lifestyle as well as the ability for capturing dietary data entry.

The web platform will be used to share participant dietary and weight data with dietitians.

Group Type: EXPERIMENTAL

Dietitian-led Approach

Intervention Type: BEHAVIORAL

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.

From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.

In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.

Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis.

Interventions

Self-Guided Approach

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.

From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.

In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.

Intervention Type: BEHAVIORAL

Dietitian-led Approach

For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.

From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.

In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.

Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 24-hour ambulatory SBP 120-160 mmHg
• BMI ≥ 25 kg/m2
• Access to a telephone
• Access to a computer or smartphone with internet access
• Complete dietary data entry for at least 5 out of 7 days during run-in period
• Enter weight into the platform during run-in period

Exclusion Criteria

• Inability to understand English
• Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within last 6 months.
• Current treatment for malignancy
• Planned or previous bariatric surgery
• Pregnant, breast-feeding, or planned pregnancy prior to the end of participation
• Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking.
• Psychiatric hospitalization in past year
• Current symptoms of angina
• Planning to leave the area prior to end of the study
• Current participation in another clinical trial
• Principal investigator discretion (i.e. concerns about safety, compliance)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States

Countries

United States

References

Chang AR, Gummo L, Yule C, Bonaparte H, Collins C, Naylor A, Appel LJ, Juraschek SP, Bailey-Davis L. Effects of a Dietitian-Led, Telehealth Lifestyle Intervention on Blood Pressure: Results of a Randomized, Controlled Trial. J Am Heart Assoc. 2022 Oct 4;11(19):e027213. doi: 10.1161/JAHA.122.027213. Epub 2022 Sep 29.

Reference Type: DERIVED

PMID: 36172955 (View on PubMed)

Taher M, Yule C, Bonaparte H, Kwiecien S, Collins C, Naylor A, Juraschek SP, Bailey-Davis L, Chang AR. Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial. BMJ Open. 2021 Mar 3;11(3):e044292. doi: 10.1136/bmjopen-2020-044292.

Reference Type: DERIVED

PMID: 33658261 (View on PubMed)

Other Identifiers

2018-0433

Identifier Type: -

Identifier Source: org_study_id