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A Trial to Examine the Effects of a Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan)

ConditionOverweight , Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorMidwest Center for Metabolic and Cardiovascular Research

About this trial

The purpose of this study is to learn whether following an online weight loss program with specific dietary and exercise goals (the 30-30-30 plan) can help improve weight loss and other markers of health when compared to an online weight loss program on its own.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individual is a male or female and 18 to 69 years of age, inclusive.

Individual has a self-reported desire to lose weight.

Individual has a body mass index (BMI) ≥27.0 and ≤45.0 kg/m2.

Individual has calculated energy needs of ≥1800 kcal/d per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.

Disqualifiers

Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.

Individual is unable to walk ¼ mile unaided without stopping.

Individual has a health condition (e.g., chronic pain, orthopedic limitations, heart problems) that would make weight loss or unsupervised exercise unsafe or infeasible. If an individual responds "yes" to any of the questions on the Physical Activity Readiness Questionnaire (PAR-Q) during visit 1, it is up to the Investigator's discretion to determine if unsupervised exercise is safe.

Individual habitually consumes >9 g fiber per 1000 kcal per day based on their responses on the fiber intake questionnaire.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 30-30-30 PFE Intervention

    Behavioral

    Interactive, online weight loss program adapted from the Rx Weight Loss (Rx WL) program with additional goals to consume ≥30 g protein/meal (P) + ≥30 g fiber/day (F) + ≥30 minutes of daily exercise (E).

  • Standard

    Behavioral

    Standard interactive, online weight loss program adapted from the Rx WL program.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: StandardActive comparator 1 intervention
Group B: 30-30-30 PFE interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body Weight

Percentage change in body weight

Time frame
From week 0 to week 24

Secondary outcomes

1

Body Weight

Percentage change in body weight

Time frame
From week 0 to week 8
2

Body Weight

Percentage change in body weight

Time frame
From week 0 to week 16
3

Waist Circumference

Percentage change in waist circumference

Time frame
From week 0 to week 8
4

Waist Circumference

Percentage change in waist circumference

Time frame
From week 0 to week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Midwest Center for Metabolic and Cardiovascular Research

Lead sponsor

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Collaborator

Source ClinicalTrials.gov
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