Clinical trial NCT05015491: Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
Official title: A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NASH
Fatty Liver
NAFLD
Weight Loss
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
Collaborators: name: Arizona Liver Health
First posted: 2021-08-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.


Eligibility criteria: Inclusion Criteria:

* Male or female, \>18 years of age, inclusive, at Day -7.
* BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -7.
* Has no plan to change smoking habits during the study period.
* Has ability to access study related online programs and apps.
* Willing to follow study instructions, as well as complete online questionnaires.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.

Exclusion Criteria:

* Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
* Self-reported type 1 diabetes.
* History of gastrointestinal surgery for weight reducing purposes.
* Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -7.
* Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
* Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
* Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
* Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -7.
* Exposure to any non-registered drug product within 30 d of Day -7.
* Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or

  1½ oz distilled spirits).
* ALT or AST \> 5 x ULN at baseline.

Primary outcomes:
measure: Change in BMI
timeFrame: baseline to day 112
Secondary outcomes:
measure: Fibroscan
timeFrame: Baseline to day 112
measure: Fibroscan - from baseline to day 112
timeFrame: Baseline to day 112
measure: Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score
timeFrame: Baseline to day 168
measure: Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).
timeFrame: Baseline to day 168
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
Study officials:
References: